Trial Outcomes & Findings for A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff (NCT NCT04497987)
NCT ID: NCT04497987
Last Updated: 2022-02-04
Results Overview
The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1180 participants
Primary outcome timeframe
Week 8 after randomization
Results posted on
2022-02-04
Participant Flow
This trial was planned as a 3-part study. Part 1 was to evaluate the efficacy and safety of bamlanivimab (BAM) in preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19), compared with Placebo (PBO). Part 2 was to demonstrate superior efficacy of BAM and BAM + ETE over PBO in the prevention of COVID-19. Part 3 was exploratory cohort.
Enrollment for Part 2 was not initiated because the efficacy of BAM 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
Participant milestones
| Measure |
Placebo
Participants received single IV infusion of Placebo.
|
4200 mg Bamlanivimab
Participants received single IV infusion of 4200 milligrams (mg) bamlanivimab.
|
|---|---|---|
|
Overall Study
STARTED
|
592
|
588
|
|
Overall Study
Received at Least One Dose of Study Drug
|
587
|
588
|
|
Overall Study
Prevention Population
|
485
|
487
|
|
Overall Study
Treatment Population
|
68
|
66
|
|
Overall Study
Serology Positive
|
36
|
35
|
|
Overall Study
COMPLETED
|
493
|
521
|
|
Overall Study
NOT COMPLETED
|
99
|
67
|
Reasons for withdrawal
| Measure |
Placebo
Participants received single IV infusion of Placebo.
|
4200 mg Bamlanivimab
Participants received single IV infusion of 4200 milligrams (mg) bamlanivimab.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
21
|
13
|
|
Overall Study
Lost to Follow-up
|
19
|
17
|
|
Overall Study
Other - as reported by the investigator
|
22
|
16
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
35
|
21
|
Baseline Characteristics
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff
Baseline characteristics by cohort
| Measure |
Placebo
n=587 Participants
Participants received single IV infusion of Placebo.
|
4200 mg Bamlanivimab
n=588 Participants
Participants received single IV infusion of 4200 mg bamlanivimab.
|
Total
n=1175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 20.3 • n=99 Participants
|
53.4 years
STANDARD_DEVIATION 20.7 • n=107 Participants
|
52.8 years
STANDARD_DEVIATION 20.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
443 Participants
n=99 Participants
|
434 Participants
n=107 Participants
|
877 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=99 Participants
|
154 Participants
n=107 Participants
|
298 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
551 Participants
n=99 Participants
|
561 Participants
n=107 Participants
|
1112 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
515 Participants
n=99 Participants
|
519 Participants
n=107 Participants
|
1034 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
587 Participants
n=99 Participants
|
588 Participants
n=107 Participants
|
1175 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 8 after randomizationPopulation: All randomized participants from prevention population.
The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
Outcome measures
| Measure |
Placebo
n=485 Participants
Participants received single IV infusion of Placebo.
|
4200mg Bamlanivimab
n=487 Participants
Participants received single IV infusion of 4200mg bamlanivimab.
|
|---|---|---|
|
Percentage of Participants With COVID-19
|
15.7 Percentage of Participants
Interval 12.5 to 18.9
|
8.3 Percentage of Participants
Interval 5.8 to 10.7
|
SECONDARY outcome
Timeframe: Week 8 after randomizationPopulation: All randomized participants from prevention population.
The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
Outcome measures
| Measure |
Placebo
n=485 Participants
Participants received single IV infusion of Placebo.
|
4200mg Bamlanivimab
n=487 Participants
Participants received single IV infusion of 4200mg bamlanivimab.
|
|---|---|---|
|
Percentage of Participants With Moderate or Worse Severity COVID-19
|
14.7 Percentage of Participants
Interval 11.5 to 17.8
|
8.1 Percentage of Participants
Interval 5.6 to 10.5
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants from prevention population.
Percentage of Participants with SARS-CoV-2.
Outcome measures
| Measure |
Placebo
n=485 Participants
Participants received single IV infusion of Placebo.
|
4200mg Bamlanivimab
n=487 Participants
Participants received single IV infusion of 4200mg bamlanivimab.
|
|---|---|---|
|
Percentage of Participants With SARS-CoV-2
|
23.1 Percentage of Participants
Interval 19.4 to 26.9
|
17.8 Percentage of Participants
Interval 14.4 to 21.2
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants from prevention population.
Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.
Outcome measures
| Measure |
Placebo
n=485 Participants
Participants received single IV infusion of Placebo.
|
4200mg Bamlanivimab
n=487 Participants
Participants received single IV infusion of 4200mg bamlanivimab.
|
|---|---|---|
|
Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19
|
1.4 Percentage of Participants
Interval 0.4 to 2.5
|
0.4 Percentage of Participants
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants from prevention population.
Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.
Outcome measures
| Measure |
Placebo
n=485 Participants
Participants received single IV infusion of Placebo.
|
4200mg Bamlanivimab
n=487 Participants
Participants received single IV infusion of 4200mg bamlanivimab.
|
|---|---|---|
|
Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
|
1.4 Percentage of Participants
Interval 0.4 to 2.5
|
0.6 Percentage of Participants
Interval 0.0 to 1.3
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants from prevention population.
Percentage of Participants Who Die Due to COVID-19.
Outcome measures
| Measure |
Placebo
n=485 Participants
Participants received single IV infusion of Placebo.
|
4200mg Bamlanivimab
n=487 Participants
Participants received single IV infusion of 4200mg bamlanivimab.
|
|---|---|---|
|
Percentage of Participants Who Die Due to COVID-19
|
0.8 Percentage of Participants
Interval 0.0 to 1.6
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 29, 57, 85, 141 and 169Population: All randomized participants who received at least one dose of bamlanivimab and had evaluable PK data.
Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.
Outcome measures
| Measure |
Placebo
n=557 Participants
Participants received single IV infusion of Placebo.
|
4200mg Bamlanivimab
Participants received single IV infusion of 4200mg bamlanivimab.
|
|---|---|---|
|
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Day 29
|
162 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 44.4
|
—
|
|
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Day 57
|
61.8 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 59.9
|
—
|
|
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Day 85
|
28.4 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 61.6
|
—
|
|
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Day 141
|
17.5 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 46.2
|
—
|
|
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Day 169
|
15.1 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 42.3
|
—
|
Adverse Events
Placebo
Serious events: 30 serious events
Other events: 147 other events
Deaths: 21 deaths
4200mg Bamlanivimab
Serious events: 39 serious events
Other events: 145 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Placebo
n=587 participants at risk
Participants received single IV infusion of Placebo.
|
4200mg Bamlanivimab
n=588 participants at risk
Participants received single IV infusion of 4200mg bamlanivimab.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.51%
3/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.34%
2/587 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Thyrotoxic crisis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Death
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Gait disturbance
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Sudden death
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Acquired immunodeficiency syndrome
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bacteraemia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Osteomyelitis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
0.51%
3/587 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.51%
3/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Septic shock
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.85%
5/588 • Number of events 6 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Open globe injury
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dementia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.23%
1/443 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/434 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
End stage renal disease
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypovolaemic shock
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=587 participants at risk
Participants received single IV infusion of Placebo.
|
4200mg Bamlanivimab
n=588 participants at risk
Participants received single IV infusion of 4200mg bamlanivimab.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiomegaly
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.51%
3/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Sinus bradycardia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.85%
5/588 • Number of events 5 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye discharge
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye pruritus
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Retinal detachment
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.51%
3/587 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.51%
3/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Faecaloma
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.51%
3/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oral pain
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Face oedema
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Feeling hot
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site extravasation
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Puncture site haematoma
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Swelling face
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Food allergy
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Serum sickness
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Abscess
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.51%
3/587 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Candida infection
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Device related infection
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Ear infection
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Eye infection
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Fungal infection
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Kidney infection
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Localised infection
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pilonidal cyst
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
1.2%
7/587 • Number of events 7 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Rhinitis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
1.4%
8/587 • Number of events 8 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tooth abscess
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.51%
3/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.51%
3/588 • Number of events 4 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
20/587 • Number of events 22 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
11/588 • Number of events 13 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/443 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/434 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral infection
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.51%
3/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
9/587 • Number of events 12 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
6/588 • Number of events 6 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Amylase increased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood glucose increased
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood pressure increased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.51%
3/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood sodium decreased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood urea increased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
C-reactive protein increased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Capillary nail refill test abnormal
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haemoglobin increased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Neutrophil count increased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Procalcitonin increased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/443 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/434 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Troponin increased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cell count increased
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.51%
3/587 • Number of events 4 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperproteinaemia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Vitamin b complex deficiency
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.68%
4/587 • Number of events 4 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
7/588 • Number of events 8 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
6/587 • Number of events 6 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.85%
5/588 • Number of events 5 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.51%
3/587 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.68%
4/588 • Number of events 4 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Trochlear dysplasia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.23%
1/443 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/434 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.69%
1/144 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/154 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
1.0%
6/587 • Number of events 6 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.85%
5/588 • Number of events 6 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness postural
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.51%
3/587 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anorgasmia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety disorder
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Delusion
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.51%
3/588 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Mental status changes
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Bladder spasm
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.51%
3/587 • Number of events 3 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal failure
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal impairment
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast mass
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/443 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/434 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.23%
1/443 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/434 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/443 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/434 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.85%
5/587 • Number of events 5 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal paraesthesia
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.85%
5/588 • Number of events 5 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin wrinkling
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.68%
4/588 • Number of events 4 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Dental operation
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Retinopexy
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Salpingo-oophorectomy unilateral
|
0.23%
1/443 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/434 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Flushing
|
0.34%
2/587 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.34%
2/588 • Number of events 2 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Haematoma
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
1.9%
11/587 • Number of events 11 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
8/588 • Number of events 8 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.17%
1/587 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/588 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/587 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.17%
1/588 • Number of events 1 • Baseline, up to 9 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60