Trial Outcomes & Findings for Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study) (NCT NCT01601704)
NCT ID: NCT01601704
Last Updated: 2017-02-27
Results Overview
The primary endpoint is the time from randomization to the first confirmed occurrence of any event within the primary MACE composite (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Due to early termination of the study, pre-planned 50% interim analysis is considered the primary analysis for outcome measures. The pre-planned 50% interim analysis was conducted when 50% of the total planned MACE were observed.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
8910 participants
Primary outcome timeframe
Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
Results posted on
2017-02-27
Participant Flow
Participant milestones
| Measure |
NB32
NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
Placebo
Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
|---|---|---|
|
Overall Study
STARTED
|
4456
|
4454
|
|
Overall Study
Treated
|
4455
|
4450
|
|
Overall Study
COMPLETED
|
4455
|
4450
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
NB32
NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
Placebo
Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
|---|---|---|
|
Overall Study
Randomized but not dispensed study med
|
1
|
4
|
Baseline Characteristics
BMI was calculated at the site. Data are missing for 3 participants for whom the site did not calculate BMI, although weight and height were measured.
Baseline characteristics by cohort
| Measure |
NB32
n=4455 Participants
NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
Placebo
n=4450 Participants
Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
Total
n=8905 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4455 Participants
|
0 Participants
n=4450 Participants
|
0 Participants
n=8905 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2973 Participants
n=4455 Participants
|
3053 Participants
n=4450 Participants
|
6026 Participants
n=8905 Participants
|
|
Age, Categorical
>=65 years
|
1482 Participants
n=4455 Participants
|
1397 Participants
n=4450 Participants
|
2879 Participants
n=8905 Participants
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 7.27 • n=4455 Participants
|
60.9 years
STANDARD_DEVIATION 7.38 • n=4450 Participants
|
61.0 years
STANDARD_DEVIATION 7.33 • n=8905 Participants
|
|
Sex: Female, Male
Female
|
2437 Participants
n=4455 Participants
|
2419 Participants
n=4450 Participants
|
4856 Participants
n=8905 Participants
|
|
Sex: Female, Male
Male
|
2018 Participants
n=4455 Participants
|
2031 Participants
n=4450 Participants
|
4049 Participants
n=8905 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
279 Participants
n=4455 Participants
|
291 Participants
n=4450 Participants
|
570 Participants
n=8905 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4174 Participants
n=4455 Participants
|
4156 Participants
n=4450 Participants
|
8330 Participants
n=8905 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=4455 Participants
|
3 Participants
n=4450 Participants
|
5 Participants
n=8905 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=4455 Participants
|
20 Participants
n=4450 Participants
|
31 Participants
n=8905 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=4455 Participants
|
27 Participants
n=4450 Participants
|
46 Participants
n=8905 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=4455 Participants
|
6 Participants
n=4450 Participants
|
12 Participants
n=8905 Participants
|
|
Race (NIH/OMB)
Black or African American
|
656 Participants
n=4455 Participants
|
648 Participants
n=4450 Participants
|
1304 Participants
n=8905 Participants
|
|
Race (NIH/OMB)
White
|
3738 Participants
n=4455 Participants
|
3698 Participants
n=4450 Participants
|
7436 Participants
n=8905 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=4455 Participants
|
NA Participants
n=4450 Participants
|
NA Participants
n=8905 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=4455 Participants
|
51 Participants
n=4450 Participants
|
76 Participants
n=8905 Participants
|
|
Region of Enrollment
United States
|
4455 Participants
n=4455 Participants
|
4450 Participants
n=4450 Participants
|
8905 Participants
n=8905 Participants
|
|
Weight
|
105.6 kilogram
STANDARD_DEVIATION 19.09 • n=4455 Participants
|
106.3 kilogram
STANDARD_DEVIATION 19.18 • n=4450 Participants
|
106.0 kilogram
STANDARD_DEVIATION 19.14 • n=8905 Participants
|
|
Body Mass Index (BMI)
|
37.2 kg/m^2
STANDARD_DEVIATION 5.26 • n=4452 Participants • BMI was calculated at the site. Data are missing for 3 participants for whom the site did not calculate BMI, although weight and height were measured.
|
37.4 kg/m^2
STANDARD_DEVIATION 5.44 • n=4450 Participants • BMI was calculated at the site. Data are missing for 3 participants for whom the site did not calculate BMI, although weight and height were measured.
|
37.3 kg/m^2
STANDARD_DEVIATION 5.35 • n=8902 Participants • BMI was calculated at the site. Data are missing for 3 participants for whom the site did not calculate BMI, although weight and height were measured.
|
|
Cardiovascular (CV) risk group
CV disease without T2DM (type 2 diabetes mellitus)
|
670 Participants
n=4455 Participants
|
646 Participants
n=4450 Participants
|
1316 Participants
n=8905 Participants
|
|
Cardiovascular (CV) risk group
CV disease with T2DM
|
745 Participants
n=4455 Participants
|
801 Participants
n=4450 Participants
|
1546 Participants
n=8905 Participants
|
|
Cardiovascular (CV) risk group
T2DM without CV disease
|
3039 Participants
n=4455 Participants
|
3002 Participants
n=4450 Participants
|
6041 Participants
n=8905 Participants
|
|
Hypertension
Yes
|
4162 Participants
n=4455 Participants
|
4117 Participants
n=4450 Participants
|
8279 Participants
n=8905 Participants
|
|
Hypertension
No
|
293 Participants
n=4455 Participants
|
333 Participants
n=4450 Participants
|
626 Participants
n=8905 Participants
|
|
Dyslipidemia
Yes
|
4100 Participants
n=4455 Participants
|
4070 Participants
n=4450 Participants
|
8170 Participants
n=8905 Participants
|
|
Dyslipidemia
No
|
355 Participants
n=4455 Participants
|
380 Participants
n=4450 Participants
|
735 Participants
n=8905 Participants
|
|
History of Depression
Yes
|
1031 Participants
n=4455 Participants
|
995 Participants
n=4450 Participants
|
2026 Participants
n=8905 Participants
|
|
History of Depression
No
|
3424 Participants
n=4455 Participants
|
3455 Participants
n=4450 Participants
|
6879 Participants
n=8905 Participants
|
|
Baseline Antidepressant Medication Use
|
1042 Participants
n=4455 Participants
|
1015 Participants
n=4450 Participants
|
2057 Participants
n=8905 Participants
|
PRIMARY outcome
Timeframe: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-upPopulation: Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.
The primary endpoint is the time from randomization to the first confirmed occurrence of any event within the primary MACE composite (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Due to early termination of the study, pre-planned 50% interim analysis is considered the primary analysis for outcome measures. The pre-planned 50% interim analysis was conducted when 50% of the total planned MACE were observed.
Outcome measures
| Measure |
NB32
n=4455 Participants
NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
Placebo
n=4450 Participants
Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
|---|---|---|
|
Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE)
|
90 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-upPopulation: Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.
Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
Outcome measures
| Measure |
NB32
n=4455 Participants
NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
Placebo
n=4450 Participants
Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
|---|---|---|
|
Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization
|
133 Participants
|
142 Participants
|
SECONDARY outcome
Timeframe: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-upPopulation: Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.
Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
Outcome measures
| Measure |
NB32
n=4455 Participants
NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
Placebo
n=4450 Participants
Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
|---|---|---|
|
Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)
|
17 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-upPopulation: Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.
Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
Outcome measures
| Measure |
NB32
n=4455 Participants
NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
Placebo
n=4450 Participants
Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
|---|---|---|
|
Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)
|
55 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-upPopulation: Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.
Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
Outcome measures
| Measure |
NB32
n=4455 Participants
NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
Placebo
n=4450 Participants
Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
|---|---|---|
|
Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)
|
22 Participants
|
21 Participants
|
Adverse Events
NB32
Serious events: 463 serious events
Other events: 1157 other events
Deaths: 0 deaths
Placebo
Serious events: 386 serious events
Other events: 282 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NB32
n=4455 participants at risk
NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
Placebo
n=4450 participants at risk
Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.04%
2/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.09%
4/4455 • Number of events 6 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.25%
11/4455 • Number of events 11 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.16%
7/4450 • Number of events 7 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Angina pectoris
|
0.38%
17/4455 • Number of events 17 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.34%
15/4450 • Number of events 15 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Angina unstable
|
0.49%
22/4455 • Number of events 25 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.34%
15/4450 • Number of events 16 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Aortic valve disease
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Arrhythmia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
12/4455 • Number of events 12 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.34%
15/4450 • Number of events 15 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Atrial flutter
|
0.09%
4/4455 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Atrial tachycardia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Atrioventricular block
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Cardiac arrest
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Cardiac failure
|
0.04%
2/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.29%
13/4455 • Number of events 16 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.18%
8/4450 • Number of events 11 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Chronotropic incompetence
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Coronary artery disease
|
0.47%
21/4455 • Number of events 22 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.47%
21/4450 • Number of events 21 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.11%
5/4450 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.31%
14/4455 • Number of events 14 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.29%
13/4450 • Number of events 13 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Pericardial effusion
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Tachycardia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Congenital, familial and genetic disorders
Porphyria acute
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Endocrine disorders
Goitre
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Enteritis
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Haematochezia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Hiatus hernia, obstructive
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.02%
1/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.02%
1/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.20%
9/4455 • Number of events 10 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
2/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Asthenia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Chest discomfort
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Chest pain
|
0.34%
15/4455 • Number of events 15 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.20%
9/4450 • Number of events 9 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Cyst
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Death
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Device dislocation
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Device malfunction
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Fat tissue increased
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Ischaemic ulcer
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.49%
22/4455 • Number of events 22 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.29%
13/4450 • Number of events 13 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Pyrexia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Surgical failure
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Unevaluable event
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Biliary colic
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.11%
5/4450 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Immune system disorders
Hypersensitivity
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Abscess
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Abscess limb
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Appendicitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Bronchitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Bursitis infective staphylococcal
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Cellulitis
|
0.36%
16/4455 • Number of events 17 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.18%
8/4450 • Number of events 8 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Clostridium difficile infection
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Colonic abscess
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Diverticulitis
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.13%
6/4450 • Number of events 7 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.07%
3/4455 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Human ehrlichiosis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Infected bites
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Infection
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Influenza
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Intervertebral discitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Lobar pneumonia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Osteomyelitis
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Perirectal abscess
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Pneumonia
|
0.27%
12/4455 • Number of events 13 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.22%
10/4450 • Number of events 10 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Sepsis
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.11%
5/4450 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Septic shock
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Staphylococcal infection
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.11%
5/4455 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.02%
1/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Blood potassium decreased
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Blood potassium increased
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Blood pressure increased
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Thyroid function test abnormal
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Troponin increased
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Alkalosis hypochloraemic
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.13%
6/4455 • Number of events 6 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.11%
5/4455 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Obesity
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.02%
1/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.11%
5/4455 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.18%
8/4455 • Number of events 9 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.90%
40/4455 • Number of events 42 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.92%
41/4450 • Number of events 44 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathy
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.02%
1/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Resorption bone increased
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell unclassifiable lymphoma high grade
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.13%
6/4455 • Number of events 6 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.11%
5/4450 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spleen
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian granulosa cell tumour
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.13%
6/4450 • Number of events 6 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Aphasia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Carotid artery disease
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Cerebral infarction
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.16%
7/4455 • Number of events 7 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.11%
5/4450 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Complicated migraine
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Convulsion
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Dementia with Lewy bodies
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Dizziness
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Encephalopathy
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Headache
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Hemiparesis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Hydrocephalus
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Ischaemic stroke
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Lacunar infarction
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Syncope
|
0.16%
7/4455 • Number of events 7 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.13%
6/4450 • Number of events 6 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.04%
2/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Bipolar disorder
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Delirium
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Hallucination
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Major depression
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Mental status changes
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Renal failure acute
|
0.18%
8/4455 • Number of events 8 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.25%
11/4450 • Number of events 11 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Cystocele
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Rectocele
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.13%
6/4455 • Number of events 10 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.13%
6/4450 • Number of events 7 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.09%
4/4455 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Surgical and medical procedures
Gastrectomy
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Surgical and medical procedures
Hip surgery
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Aortic aneurysm
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Arterial occlusive disease
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Haematoma
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Hypertensive crisis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Hypotension
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Iliac artery occlusion
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Orthostatic hypotension
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
Other adverse events
| Measure |
NB32
n=4455 participants at risk
NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
Placebo
n=4450 participants at risk
Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Bradycardia
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Cardiac discomfort
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Cardiac flutter
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Extrasystoles
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Palpitations
|
0.45%
20/4455 • Number of events 20 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.11%
5/4450 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Cardiac disorders
Tachycardia
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.11%
5/4455 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
0.25%
11/4455 • Number of events 11 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Eye disorders
Blepharospasm
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Eye disorders
Diplopia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Eye disorders
Vision blurred
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.61%
27/4455 • Number of events 27 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
18/4455 • Number of events 18 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.13%
6/4450 • Number of events 6 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.40%
18/4455 • Number of events 18 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
129/4455 • Number of events 129 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.34%
15/4450 • Number of events 15 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.79%
35/4455 • Number of events 35 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.47%
21/4450 • Number of events 21 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Diverticulum
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
0.47%
21/4455 • Number of events 21 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.27%
12/4455 • Number of events 12 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Eructation
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Flatulence
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Gastritis
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.13%
6/4455 • Number of events 6 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Haematemesis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Haematochezia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Lip swelling
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Nausea
|
7.8%
346/4455 • Number of events 346 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.47%
21/4450 • Number of events 21 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Retching
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Stomatitis
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
89/4455 • Number of events 89 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Asthenia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Chest discomfort
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Chest pain
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Drug intolerance
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Fatigue
|
0.29%
13/4455 • Number of events 13 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Feeling abnormal
|
0.16%
7/4455 • Number of events 7 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Feeling cold
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Feeling jittery
|
0.36%
16/4455 • Number of events 16 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Feeling of body temperature change
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Gait disturbance
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Generalised oedema
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Influenza like illness
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Local swelling
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Mucosal dryness
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
General disorders
Pain
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Immune system disorders
Drug hypersensitivity
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Acute sinusitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Bronchitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Diverticulitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Helicobacter infection
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Impetigo
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Influenza
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Pneumonia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Sinusitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Infections and infestations
Viral infection
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Blood creatinine increased
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Blood glucose decreased
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Blood glucose increased
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Blood pressure increased
|
0.45%
20/4455 • Number of events 20 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.31%
14/4450 • Number of events 14 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Blood pressure systolic increased
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Grip strength decreased
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Heart rate increased
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Hepatic enzyme increased
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Prostatic specific antigen increased
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Investigations
Weight increased
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.13%
6/4455 • Number of events 6 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.11%
5/4450 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.25%
11/4450 • Number of events 11 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.11%
5/4455 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Altered state of consciousness
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Amnesia
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Balance disorder
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Burning sensation
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Disturbance in attention
|
0.16%
7/4455 • Number of events 7 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Dizziness
|
1.4%
64/4455 • Number of events 67 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.18%
8/4450 • Number of events 8 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Dizziness postural
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Dysgeusia
|
0.36%
16/4455 • Number of events 16 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Dysgraphia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Dyskinesia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Essential tremor
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Headache
|
1.1%
51/4455 • Number of events 51 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.34%
15/4450 • Number of events 15 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Hypoaesthesia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Lethargy
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Memory impairment
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.09%
4/4450 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Migraine
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Multiple sclerosis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Nerve compression
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Neurodegenerative disorder
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Paraesthesia
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Somnolence
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Spinal meningeal cyst
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
Tremor
|
1.8%
80/4455 • Number of events 81 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Abnormal dreams
|
0.11%
5/4455 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Affect lability
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Agitation
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Anger
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Anxiety
|
0.58%
26/4455 • Number of events 26 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.18%
8/4450 • Number of events 8 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Apathy
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Aversion
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Bruxism
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Confusional state
|
0.11%
5/4455 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Depression
|
0.11%
5/4455 • Number of events 5 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.22%
10/4450 • Number of events 10 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Disorientation
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Fear
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Hallucination
|
0.22%
10/4455 • Number of events 10 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Hallucination, visual
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Insomnia
|
0.85%
38/4455 • Number of events 38 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.36%
16/4450 • Number of events 16 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Irritability
|
0.16%
7/4455 • Number of events 7 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Libido decreased
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Major depression
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Mental disorder
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Middle insomnia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Mood altered
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Mood swings
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Nervousness
|
0.18%
8/4455 • Number of events 8 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Nightmare
|
0.13%
6/4455 • Number of events 6 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Panic attack
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Personality change
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Psychomotor retardation
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Restlessness
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Sleep disorder
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Sleep talking
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Sleep terror
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Dysuria
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Glomerulosclerosis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Haematuria
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Renal colic
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Renal impairment
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.18%
8/4455 • Number of events 8 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.04%
2/4455 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.13%
6/4455 • Number of events 6 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.09%
4/4455 • Number of events 4 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.22%
10/4455 • Number of events 10 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.13%
6/4455 • Number of events 6 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.07%
3/4450 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.02%
1/4455 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Flushing
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Hot flush
|
0.22%
10/4455 • Number of events 10 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.04%
2/4450 • Number of events 2 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Hypertension
|
0.56%
25/4455 • Number of events 25 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.25%
11/4450 • Number of events 11 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Hypotension
|
0.07%
3/4455 • Number of events 3 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.00%
0/4450 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/4455 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
0.02%
1/4450 • Number of events 1 • Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If not already published by Sponsor as part of a multi-center publication, 24 months after conclusion, abandonment or termination of the study or notification that there will be no such multi-center publication, PI may publish the results for PI's study center individually. Prior to such publication, PI must provide Sponsor with at least 90 days to review and comment on the proposed publication. Sponsor may delay publication for up to an additional 6-month period to file for patent protection.
- Publication restrictions are in place
Restriction type: OTHER