Trial Outcomes & Findings for An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) (NCT NCT02257736)
NCT ID: NCT02257736
Last Updated: 2025-11-12
Results Overview
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
982 participants
Primary outcome timeframe
Up to 3 years and 4 months
Results posted on
2025-11-12
Participant Flow
Treatment disposition has been reported in participant flow.
Participant milestones
| Measure |
Placebo+ Abiraterone Acetate - Prednisolone
Participants received 4\*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4\*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
Apalutamide + Abiraterone Acetate - Prednisolone
Participants received 4\*60 mg tablets of apalutamide tablets orally qd with or without food and 4\*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
|---|---|---|
|
Overall Study
STARTED
|
490
|
492
|
|
Overall Study
COMPLETED
|
39
|
45
|
|
Overall Study
NOT COMPLETED
|
451
|
447
|
Reasons for withdrawal
| Measure |
Placebo+ Abiraterone Acetate - Prednisolone
Participants received 4\*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4\*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
Apalutamide + Abiraterone Acetate - Prednisolone
Participants received 4\*60 mg tablets of apalutamide tablets orally qd with or without food and 4\*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
|---|---|---|
|
Overall Study
Progressive disease
|
365
|
327
|
|
Overall Study
Adverse Event
|
45
|
56
|
|
Overall Study
Withdrawal by Subject
|
21
|
38
|
|
Overall Study
Death
|
11
|
6
|
|
Overall Study
Physician Decision
|
5
|
9
|
|
Overall Study
Non-Compliance with study drug
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Other
|
1
|
7
|
|
Overall Study
Randomized, not treated
|
1
|
2
|
Baseline Characteristics
An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Baseline characteristics by cohort
| Measure |
Placebo+ Abiraterone Acetate - Prednisolone
n=490 Participants
Participants received 4\*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4\*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
Apalutamide + Abiraterone Acetate - Prednisolone
n=492 Participants
Participants received 4\*60 mg tablets of apalutamide tablets orally qd with or without food and 4\*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
Total
n=982 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.7 years
STANDARD_DEVIATION 8.06 • n=10 Participants
|
71.4 years
STANDARD_DEVIATION 8.34 • n=10 Participants
|
71.1 years
STANDARD_DEVIATION 8.21 • n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
490 Participants
n=10 Participants
|
492 Participants
n=10 Participants
|
982 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=10 Participants
|
50 Participants
n=10 Participants
|
104 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
411 Participants
n=10 Participants
|
422 Participants
n=10 Participants
|
833 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=10 Participants
|
20 Participants
n=10 Participants
|
45 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
8 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
17 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Asian
|
53 Participants
n=10 Participants
|
58 Participants
n=10 Participants
|
111 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=10 Participants
|
19 Participants
n=10 Participants
|
37 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White
|
373 Participants
n=10 Participants
|
365 Participants
n=10 Participants
|
738 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
20 Participants
n=10 Participants
|
20 Participants
n=10 Participants
|
40 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other
|
18 Participants
n=10 Participants
|
21 Participants
n=10 Participants
|
39 Participants
n=20 Participants
|
|
Region of Enrollment
ARGENTINA
|
3 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Region of Enrollment
AUSTRALIA
|
31 Participants
n=10 Participants
|
47 Participants
n=10 Participants
|
78 Participants
n=20 Participants
|
|
Region of Enrollment
BELGIUM
|
16 Participants
n=10 Participants
|
16 Participants
n=10 Participants
|
32 Participants
n=20 Participants
|
|
Region of Enrollment
BRAZIL
|
21 Participants
n=10 Participants
|
18 Participants
n=10 Participants
|
39 Participants
n=20 Participants
|
|
Region of Enrollment
CANADA
|
12 Participants
n=10 Participants
|
18 Participants
n=10 Participants
|
30 Participants
n=20 Participants
|
|
Region of Enrollment
FRANCE
|
18 Participants
n=10 Participants
|
16 Participants
n=10 Participants
|
34 Participants
n=20 Participants
|
|
Region of Enrollment
GERMANY
|
10 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
|
Region of Enrollment
ITALY
|
33 Participants
n=10 Participants
|
36 Participants
n=10 Participants
|
69 Participants
n=20 Participants
|
|
Region of Enrollment
JAPAN
|
23 Participants
n=10 Participants
|
27 Participants
n=10 Participants
|
50 Participants
n=20 Participants
|
|
Region of Enrollment
MEXICO
|
19 Participants
n=10 Participants
|
16 Participants
n=10 Participants
|
35 Participants
n=20 Participants
|
|
Region of Enrollment
NETHERLANDS
|
14 Participants
n=10 Participants
|
16 Participants
n=10 Participants
|
30 Participants
n=20 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
59 Participants
n=10 Participants
|
46 Participants
n=10 Participants
|
105 Participants
n=20 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
9 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
17 Participants
n=20 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
28 Participants
n=10 Participants
|
29 Participants
n=10 Participants
|
57 Participants
n=20 Participants
|
|
Region of Enrollment
SPAIN
|
43 Participants
n=10 Participants
|
36 Participants
n=10 Participants
|
79 Participants
n=20 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
23 Participants
n=10 Participants
|
27 Participants
n=10 Participants
|
50 Participants
n=20 Participants
|
|
Region of Enrollment
UNITED STATES
|
128 Participants
n=10 Participants
|
124 Participants
n=10 Participants
|
252 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years and 4 monthsPopulation: Intent-to-treat (ITT) population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Outcome measures
| Measure |
Placebo+ Abiraterone Acetate - Prednisolone
n=490 Participants
Participants received 4\*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4\*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
Apalutamide + Abiraterone Acetate - Prednisolone
n=492 Participants
Participants received 4\*60 mg tablets of apalutamide tablets orally qd with or without food and 4\*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
|---|---|---|
|
Radiographic Progression-free Survival (rPFS)
|
16.59 months
Interval 13.86 to 19.32
|
23.98 months
Interval 19.71 to 27.5
|
SECONDARY outcome
Timeframe: Up to 5 years and 10 monthsPopulation: ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
The OS was defined as the time from randomization to date of death from any cause.
Outcome measures
| Measure |
Placebo+ Abiraterone Acetate - Prednisolone
n=490 Participants
Participants received 4\*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4\*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
Apalutamide + Abiraterone Acetate - Prednisolone
n=492 Participants
Participants received 4\*60 mg tablets of apalutamide tablets orally qd with or without food and 4\*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
|---|---|---|
|
Overall Survival (OS)
|
33.71 months
Interval 31.24 to 38.28
|
36.17 months
Interval 32.76 to 38.77
|
SECONDARY outcome
Timeframe: Up to 5 years and 10 monthsPopulation: ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
Time to chronic opioid use was defined as the time from date of randomization to the first date of opioid use.
Outcome measures
| Measure |
Placebo+ Abiraterone Acetate - Prednisolone
n=490 Participants
Participants received 4\*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4\*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
Apalutamide + Abiraterone Acetate - Prednisolone
n=492 Participants
Participants received 4\*60 mg tablets of apalutamide tablets orally qd with or without food and 4\*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
|---|---|---|
|
Time to Chronic Opioid Use
|
53.26 months
Interval 42.02 to
Here 'NA' represents that upper limit of CI was not estimable due to lesser number of events.
|
46.98 months
Interval 39.23 to
Here 'NA' represents that upper limit of CI was not estimable due to lesser number of events.
|
SECONDARY outcome
Timeframe: Up to 5 years and 10 monthsPopulation: ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy.
Outcome measures
| Measure |
Placebo+ Abiraterone Acetate - Prednisolone
n=490 Participants
Participants received 4\*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4\*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
Apalutamide + Abiraterone Acetate - Prednisolone
n=492 Participants
Participants received 4\*60 mg tablets of apalutamide tablets orally qd with or without food and 4\*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
|---|---|---|
|
Time to Initiation of Cytotoxic Chemotherapy
|
34.23 months
Interval 29.54 to 39.16
|
36.11 months
Interval 32.23 to 42.55
|
SECONDARY outcome
Timeframe: Up to 5 years and 10 monthsPopulation: ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
Time to pain progression: time from randomization to first date that participant either experienced an increase by 2 points from baseline in Brief Pain Inventory Short Form (BPI-SF) worst pain intensity item (item 3) or Case Report Form (CRF) pain, observed at 2 consecutive evaluations \>=4 wks apart, or initiation of chronic opioids as defined in time to chronic opioid use, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3(worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.CRF pain refers to participant's response to global pain assessment "How would you rate your pain over the past 7 days?"with a scale of 0("No pain") to 10("Pain as bad as you can imagine"),that is systematically reported and recorded on the eCRF.
Outcome measures
| Measure |
Placebo+ Abiraterone Acetate - Prednisolone
n=490 Participants
Participants received 4\*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4\*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
Apalutamide + Abiraterone Acetate - Prednisolone
n=492 Participants
Participants received 4\*60 mg tablets of apalutamide tablets orally qd with or without food and 4\*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
|---|---|---|
|
Time to Pain Progression
|
26.51 months
Interval 22.57 to 29.5
|
21.82 months
Interval 17.97 to 25.66
|
Adverse Events
Placebo+ Abiraterone Acetate - Prednisolone
Serious events: 166 serious events
Other events: 459 other events
Deaths: 350 deaths
Apalutamide + Abiraterone Acetate - Prednisolone
Serious events: 192 serious events
Other events: 472 other events
Deaths: 338 deaths
Serious adverse events
| Measure |
Placebo+ Abiraterone Acetate - Prednisolone
n=489 participants at risk
Participants received 4\*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4\*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
Apalutamide + Abiraterone Acetate - Prednisolone
n=490 participants at risk
Participants received 4\*60 mg tablets of apalutamide tablets orally qd with or without food and 4\*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
5/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.82%
4/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.82%
4/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.82%
4/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.82%
4/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.2%
6/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.61%
3/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Cardiac Failure
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.82%
4/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.82%
4/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Myocardial Infarction
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
1.2%
6/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Stress Cardiomyopathy
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Eye disorders
Cataract
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Eye disorders
Diplopia
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Anal Haemorrhage
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Diverticulum
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Diverticulum Intestinal Haemorrhagic
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Duodenal Ulcer Perforation
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Enteritis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Haematochezia
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.61%
3/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Lumbar Hernia
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Melaena
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Nausea
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Peptic Ulcer Perforation
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.0%
5/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Asthenia
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.82%
4/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Fatigue
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Gait Inability
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
General Physical Health Deterioration
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Generalised Oedema
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Granuloma
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
1.0%
5/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Oedema Peripheral
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Pyrexia
|
0.82%
4/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Hepatobiliary disorders
Cholangitis
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Hepatobiliary disorders
Cholestasis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Immune system disorders
Contrast Media Allergy
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Appendicitis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Appendicitis Perforated
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Bacteraemia
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Catheter Site Infection
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Cellulitis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Diverticulitis
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Gangrene
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Gastroenteritis
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Infection
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Influenza
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Legionella Infection
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Liver Abscess
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Osteomyelitis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Pneumonia
|
2.0%
10/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
3.7%
18/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Pneumonia Klebsiella
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Pneumonia Legionella
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Post Procedural Infection
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Prostate Infection
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Pulmonary Mycosis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Pyelonephritis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.82%
4/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Renal Abscess
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Sepsis
|
1.4%
7/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
1.0%
5/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Septic Shock
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Urinary Tract Infection
|
1.4%
7/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
2.4%
12/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Urosepsis
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
1.6%
8/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.61%
3/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Limb Traumatic Amputation
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Investigations
Oxygen Saturation Decreased
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.82%
4/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.6%
8/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.82%
4/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.61%
3/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.61%
3/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphoma
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Adenocarcinoma
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Neoplasm
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Cancer
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal Metastasis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Papillary Mucinous Neoplasm
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Presyncope
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Bone
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Malignant Melanoma
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Adenocarcinoma
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Neoplasm
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Carcinoma
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Altered State of Consciousness
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.82%
4/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Dementia
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Dizziness
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Embolic Cerebral Infarction
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Encephalopathy
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Headache
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Loss of Consciousness
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Nervous System Disorder
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Parkinson's Disease
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Seizure
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
1.0%
5/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Syncope
|
1.0%
5/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
1.2%
6/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.61%
3/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Product Issues
Device Occlusion
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Psychiatric disorders
Anxiety
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.4%
7/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
1.2%
6/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Bladder Obstruction
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Calculus Bladder
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Haematuria
|
2.7%
13/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
1.2%
6/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.82%
4/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Oliguria
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Ureteric Obstruction
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.61%
3/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Urinary Retention
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.61%
3/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.82%
4/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Reproductive system and breast disorders
Testicular Pain
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.2%
6/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Surgical and medical procedures
Coronary Angioplasty
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Aortic Aneurysm
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.41%
2/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Aortic Dissection
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Aortic Stenosis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.82%
4/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Embolism
|
0.41%
2/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Haemodynamic Instability
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Hypertension
|
0.61%
3/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Hypertensive Urgency
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Hypotension
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Pelvic Venous Thrombosis
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.20%
1/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.00%
0/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
0.20%
1/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
Other adverse events
| Measure |
Placebo+ Abiraterone Acetate - Prednisolone
n=489 participants at risk
Participants received 4\*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4\*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
Apalutamide + Abiraterone Acetate - Prednisolone
n=490 participants at risk
Participants received 4\*60 mg tablets of apalutamide tablets orally qd with or without food and 4\*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.7%
77/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
14.3%
70/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Endocrine disorders
Hypothyroidism
|
1.6%
8/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
5.5%
27/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.1%
25/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
4.9%
24/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Constipation
|
19.2%
94/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
19.6%
96/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.9%
73/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
18.6%
91/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
21/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
5.7%
28/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Nausea
|
15.5%
76/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
17.1%
84/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
7.2%
35/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
8.0%
39/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Asthenia
|
12.9%
63/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
13.3%
65/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Fatigue
|
27.4%
134/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
33.5%
164/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Oedema Peripheral
|
14.7%
72/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
15.7%
77/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
General disorders
Pyrexia
|
7.4%
36/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
7.3%
36/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Influenza
|
5.7%
28/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
4.1%
20/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
11.7%
57/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
10.6%
52/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.2%
40/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
8.6%
42/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
49/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
7.6%
37/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
49/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
6.9%
34/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
18.8%
92/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
21.6%
106/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
4.7%
23/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
5.1%
25/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Investigations
Alanine Aminotransferase Increased
|
11.7%
57/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
4.1%
20/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Investigations
Aspartate Aminotransferase Increased
|
10.8%
53/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
4.3%
21/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
7.0%
34/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
3.9%
19/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Investigations
Blood Pressure Increased
|
3.5%
17/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
5.3%
26/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Investigations
Weight Decreased
|
17.2%
84/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
27.8%
136/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Investigations
Weight Increased
|
5.7%
28/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
2.4%
12/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
12.3%
60/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
14.7%
72/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.7%
18/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
5.7%
28/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.6%
37/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
5.9%
29/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.9%
73/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
16.1%
79/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.7%
121/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
25.9%
127/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
27.2%
133/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
31.4%
154/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
9.8%
48/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
6.9%
34/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
9.2%
45/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
6.1%
30/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
10.2%
50/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
9.8%
48/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
9.4%
46/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
10.2%
50/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
28/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
5.5%
27/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.7%
13/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
5.3%
26/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
11.7%
57/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
16.1%
79/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Dizziness
|
9.4%
46/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
12.4%
61/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Dysgeusia
|
2.5%
12/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
6.7%
33/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Nervous system disorders
Headache
|
12.9%
63/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
16.1%
79/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Psychiatric disorders
Anxiety
|
3.3%
16/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
5.7%
28/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Psychiatric disorders
Insomnia
|
6.1%
30/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
9.4%
46/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Haematuria
|
8.2%
40/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
8.6%
42/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Renal and urinary disorders
Pollakiuria
|
6.3%
31/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
4.3%
21/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.5%
66/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
10.8%
53/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.8%
43/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
8.4%
41/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
24/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
9.0%
44/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Hot Flush
|
11.5%
56/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
15.1%
74/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
|
Vascular disorders
Hypertension
|
24.9%
122/489 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
29.4%
144/490 • Up to 3 years and 4 months
Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received.
|
Additional Information
Executive Medical Director
Aragon Pharmaceuticals, Inc.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER