Trial Outcomes & Findings for Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis (NCT NCT02732210)
NCT ID: NCT02732210
Last Updated: 2022-11-29
Results Overview
A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.
Recruitment status
COMPLETED
Target enrollment
935 participants
Primary outcome timeframe
12 months
Results posted on
2022-11-29
Participant Flow
The first participant was enrolled into the study on 6 July 2011 and enrollment continued until the 935th participant enrolled on the 5 April 2012. All participants were to be observed for at least 2 years, the last subjects last reported end date was 14 April 2014.
Participant milestones
| Measure |
Canada
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
|
United States
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
|
|---|---|---|
|
Overall Study
STARTED
|
303
|
632
|
|
Overall Study
COMPLETED
|
218
|
338
|
|
Overall Study
NOT COMPLETED
|
85
|
294
|
Reasons for withdrawal
| Measure |
Canada
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
|
United States
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
|
|---|---|---|
|
Overall Study
Site Closed
|
0
|
11
|
|
Overall Study
Study Ended
|
13
|
13
|
|
Overall Study
Withdrawal by Subject
|
28
|
87
|
|
Overall Study
Lost to Follow-up
|
5
|
57
|
|
Overall Study
Death
|
4
|
15
|
|
Overall Study
Other
|
35
|
103
|
|
Overall Study
Missing
|
0
|
8
|
Baseline Characteristics
Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis
Baseline characteristics by cohort
| Measure |
Canada
n=303 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
|
United States
n=632 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
|
Total
n=935 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
71.9 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
70.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Age, Customized
< 65 years
|
115 participants
n=5 Participants
|
152 participants
n=7 Participants
|
267 participants
n=5 Participants
|
|
Age, Customized
≥ 65 to < 75 years
|
102 participants
n=5 Participants
|
216 participants
n=7 Participants
|
318 participants
n=5 Participants
|
|
Age, Customized
≥ 75 years
|
86 participants
n=5 Participants
|
264 participants
n=7 Participants
|
350 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
303 Participants
n=5 Participants
|
632 Participants
n=7 Participants
|
935 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race
Asian
|
16 participants
n=5 Participants
|
9 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Race
Black or African American
|
0 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race
White
|
285 participants
n=5 Participants
|
601 participants
n=7 Participants
|
886 participants
n=5 Participants
|
|
Race
Other
|
1 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race
Mixed race
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Ethnicity
Hispanic or Latino
|
2 participants
n=5 Participants
|
45 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
301 participants
n=5 Participants
|
587 participants
n=7 Participants
|
888 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Full Analysis Set (all enrolled participants)
A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.
Outcome measures
| Measure |
Canada
n=303 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
|
United States
n=632 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
|
|---|---|---|
|
Percentage of Participants With Persistence With Prolia® at 12 Ponths
|
87.8 percentage of participants
Interval 83.6 to 91.3
|
81.0 percentage of participants
Interval 77.7 to 84.0
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Full analysis set
A participant was considered persistent with Prolia® at 24 months if they received at least 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections does not exceed 6 months plus 8 weeks (239 days).
Outcome measures
| Measure |
Canada
n=303 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
|
United States
n=632 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
|
|---|---|---|
|
Percentage of Participants With Persistence With Prolia® at 24 Months
|
74.9 percentage of participants
Interval 69.6 to 79.7
|
50.0 percentage of participants
Interval 46.0 to 54.0
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Full analysis set with non-persistence at 24 months
For non-persistent participants, time to non-persistence was calculated as the time between the date of the first injection and the date of last injection received during the period where the participant was still classified as persistent plus 6 months (183 days).
Outcome measures
| Measure |
Canada
n=76 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
|
United States
n=316 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
|
|---|---|---|
|
Time to Non-persistence
|
10.69 months
Interval 6.05 to 12.86
|
12.14 months
Interval 6.05 to 17.99
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Full analysis set
The number of injections that a participant received over 24 months (including the baseline injection) regardless of when the injection was received.
Outcome measures
| Measure |
Canada
n=303 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
|
United States
n=632 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
|
|---|---|---|
|
Number of Prolia® Injections Received
|
5.0 prolia injections
Interval 4.0 to 5.0
|
4.0 prolia injections
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full analysis set
Percentage of participants satisfying medication-taking behavior defined as, following the first Prolia® injection, the participant received a second Prolia® injection and the length of time between the first and the second Prolia® injection did not exceed 6 months with a grace period of ± 4 weeks.
Outcome measures
| Measure |
Canada
n=303 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
|
United States
n=632 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
|
|---|---|---|
|
Percentage of Participants Satisfying Medication-taking Behavior at 12 Months
|
82.2 percentage of participants
Interval 77.4 to 86.3
|
72.0 percentage of participants
Interval 68.3 to 75.5
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Full analysis set
Percentage of participants satisfying medication-taking behavior defined as the participant received all 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections did not exceed 6 months with a grace period of ± 4 weeks.
Outcome measures
| Measure |
Canada
n=303 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
|
United States
n=632 Participants
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
|
|---|---|---|
|
Percentage of Participants Satisfying Medication-taking Behavior at 24 Months
|
62.7 percentage of participants
Interval 57.0 to 68.2
|
36.4 percentage of participants
Interval 32.6 to 40.3
|
Adverse Events
Canada
Serious events: 27 serious events
Other events: 0 other events
Deaths: 0 deaths
United States
Serious events: 95 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Canada
n=303 participants at risk
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
|
United States
n=632 participants at risk
Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.32%
2/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
5/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.47%
3/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial flutter
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac arrest
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.32%
2/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.63%
4/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery embolism
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.32%
2/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.47%
3/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.32%
2/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Death
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.47%
3/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Multi-organ failure
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Aeromona infection
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.32%
2/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
5/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.47%
3/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Device related sepsis
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Empyema
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gangrene
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
9/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.63%
4/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Wound infection
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.47%
3/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.63%
4/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.32%
2/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.47%
3/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Helicobacter test positive
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.47%
3/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.66%
2/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.47%
3/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.66%
2/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.32%
2/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Convulsion
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dementia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Essential tremor
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.32%
2/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hemiplegia
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Migraine
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Sciatica
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.47%
3/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Communication disorder
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure acute
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.32%
2/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.99%
3/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.32%
2/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Spinal operation
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Arteriosclerosis
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.47%
3/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral ischaemia
|
0.33%
1/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.32%
2/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/303 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
1/632 • 24 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER