Trial Outcomes & Findings for A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP) (NCT NCT00545363)
NCT ID: NCT00545363
Last Updated: 2016-10-24
Results Overview
Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on case report form (CRF) and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
716 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2016-10-24
Participant Flow
Participant milestones
| Measure |
Bone Marker Feedback (BMF) Participants
Postmenopausal women received ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants, in this arm, received bone marker feedback (BMF) at Month 3. BMF was given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A "BMF-form" was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by patient relationship program (PRP), carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
No BMF Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
|---|---|---|
|
Overall Study
STARTED
|
358
|
358
|
|
Overall Study
Treated
|
354
|
357
|
|
Overall Study
COMPLETED
|
339
|
343
|
|
Overall Study
NOT COMPLETED
|
19
|
15
|
Reasons for withdrawal
| Measure |
Bone Marker Feedback (BMF) Participants
Postmenopausal women received ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants, in this arm, received bone marker feedback (BMF) at Month 3. BMF was given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A "BMF-form" was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by patient relationship program (PRP), carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
No BMF Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Non-compliance
|
3
|
1
|
|
Overall Study
Did not meet entry criteria
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
Baseline characteristics by cohort
| Measure |
BMF Participants
n=354 Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A "BMF-form" was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
No BMF Participants
n=357 Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
Total
n=711 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 7.12 • n=99 Participants
|
65.6 years
STANDARD_DEVIATION 6.64 • n=107 Participants
|
66.2 years
STANDARD_DEVIATION 6.90 • n=206 Participants
|
|
Sex: Female, Male
Female
|
354 Participants
n=99 Participants
|
357 Participants
n=107 Participants
|
711 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Intent to treat (ITT) population included all randomized participants. Number of participants analyzed=number of participants evaluable for this outcome.
Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on case report form (CRF) and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.
Outcome measures
| Measure |
BMF Participants
n=271 Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A "BMF-form" was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
No BMF Participants
n=284 Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
|---|---|---|
|
Percentage of Participants With Adherence to Treatment
|
98.5 percentage of participants
|
98.6 percentage of participants
|
SECONDARY outcome
Timeframe: At Month 6Population: ITT population. Number of participants analyzed = participants evaluable for this outcome.
The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1 - 6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11 - 16). Satisfaction with treatment was assessed using the OPSAT-Q composite satisfaction score, which was the average of the scores from the four domains of the OPSAT-Q converted to a 0 - 100-point scale. Higher scores indicated greater treatment satisfaction. A score of 80 or more was considered as high score.
Outcome measures
| Measure |
BMF Participants
n=328 Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A "BMF-form" was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
No BMF Participants
n=336 Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
|---|---|---|
|
Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores
|
87.72 percentage of participants
|
87.62 percentage of participants
|
SECONDARY outcome
Timeframe: At Month 6Population: ITT population. Number of participants analyzed = participants evaluable for this outcome.
OPPS: A standardized 6-item satisfaction questionnaire for osteoporosis medical care and treatment received during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction. OMSQ: A standardized 18-item satisfaction questionnaire for osteoporosis medical care, treatment received and blood test and their results during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction.
Outcome measures
| Measure |
BMF Participants
n=328 Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A "BMF-form" was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
No BMF Participants
n=334 Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
|---|---|---|
|
Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score
|
74.9 percentage of participants
|
72.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: ITT population. Number of participants analyzed = participants evaluable for this outcome and "n" represents number of participants analyzed for the specified category.
Serum CTX, a biochemical marker of bone resorption, was assessed for all participants at baseline and at final visit (Month 6). The sampling was done at the same time of the day each time to overcome the effect of circadian fluctuations. Participants were considered adherent to treatment if they took at least 83% of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on CRF and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.
Outcome measures
| Measure |
BMF Participants
n=280 Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A "BMF-form" was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
No BMF Participants
n=287 Participants
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
|---|---|---|
|
Percent Change From Baseline in CTX Based on Adherence to Ibandronate
Adherence-Yes (n=279, 281)
|
-47.5 percent change
Interval -51.3 to -43.5
|
-47.5 percent change
Interval -51.0 to -43.9
|
|
Percent Change From Baseline in CTX Based on Adherence to Ibandronate
Adherence-No (n=1, 6)
|
-71.74 percent change
Standard deviation is not applicable as there is only 1 participant.
|
-25.8 percent change
Interval -91.0 to 13.5
|
Adverse Events
BMF Participants
Serious events: 8 serious events
Other events: 196 other events
Deaths: 0 deaths
No BMF Participants
Serious events: 5 serious events
Other events: 224 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BMF Participants
n=354 participants at risk
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A "BMF-form" was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
No BMF Participants
n=357 participants at risk
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Cardiac disorders
Sinus arrhythmia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
General disorders
Sudden death
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Appendicitis
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Pneumonia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Headache
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Vascular encephalopathy
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Surgical and medical procedures
Cholecystectomy
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
Other adverse events
| Measure |
BMF Participants
n=354 participants at risk
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A "BMF-form" was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
No BMF Participants
n=357 participants at risk
Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.56%
2/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Cardiac disorders
Palpitations
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Cardiac disorders
Tachycardia
|
0.85%
3/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Cardiac disorders
Tricuspid valve disease
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Ear and labyrinth disorders
Vertigo
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Eye disorders
Cataract
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Eye disorders
Eye pain
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Eye disorders
Keratopathy
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Eye disorders
Visual impairment
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
6/354 • 15-30 days after final visit (final visit=up to 6 months)
|
1.1%
4/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
5/354 • 15-30 days after final visit (final visit=up to 6 months)
|
2.5%
9/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Constipation
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
9/354 • 15-30 days after final visit (final visit=up to 6 months)
|
3.4%
12/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
4/354 • 15-30 days after final visit (final visit=up to 6 months)
|
2.8%
10/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Gastritis
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.56%
2/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.56%
2/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Nausea
|
2.8%
10/354 • 15-30 days after final visit (final visit=up to 6 months)
|
1.4%
5/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Oral discomfort
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
General disorders
Acute phase reaction
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
General disorders
Asthenia
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
General disorders
Chest pain
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
General disorders
Chills
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
General disorders
Fatigue
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.56%
2/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
General disorders
Hyperthermia
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
General disorders
Influenza like illness
|
1.1%
4/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
General disorders
Malaise
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
General disorders
Pyrexia
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.56%
2/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Hepatobiliary disorders
Hepatic pain
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Immune system disorders
Food allergy
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Abscess
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Bronchitis
|
0.85%
3/354 • 15-30 days after final visit (final visit=up to 6 months)
|
1.4%
5/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Conjunctivitis
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Cystitis
|
1.4%
5/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.84%
3/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Fungal infection
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Herpes zoster
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Influenza
|
0.85%
3/354 • 15-30 days after final visit (final visit=up to 6 months)
|
1.1%
4/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
6/354 • 15-30 days after final visit (final visit=up to 6 months)
|
2.8%
10/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Otitis media
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Pharyngitis
|
0.85%
3/354 • 15-30 days after final visit (final visit=up to 6 months)
|
1.1%
4/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.56%
2/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Pyelonephritis
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.56%
2/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Urinary tract infection
|
1.7%
6/354 • 15-30 days after final visit (final visit=up to 6 months)
|
1.1%
4/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Viral infection
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.56%
2/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Injury, poisoning and procedural complications
Burn oesophageal
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.85%
3/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Investigations
Blood creatinine increased
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Investigations
Blood glucose increased
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Investigations
Blood potassium decreased
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Investigations
Laboratory test abnormal
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Investigations
Urine output increased
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.56%
2/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Metabolism and nutrition disorders
Lipid metabolism disorder
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
11/354 • 15-30 days after final visit (final visit=up to 6 months)
|
3.1%
11/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
8/354 • 15-30 days after final visit (final visit=up to 6 months)
|
3.6%
13/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.85%
3/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.84%
3/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.85%
3/354 • 15-30 days after final visit (final visit=up to 6 months)
|
1.1%
4/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
2.0%
7/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.84%
3/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.56%
2/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
5/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.56%
2/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Cerebral infarction
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Disturbance in attention
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Dizziness
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Dysgeusia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Headache
|
1.1%
4/354 • 15-30 days after final visit (final visit=up to 6 months)
|
2.0%
7/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Migraine
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Paraesthesia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Psychiatric disorders
Anxiety disorder
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Psychiatric disorders
Depression
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Psychiatric disorders
Insomnia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Psychiatric disorders
Panic disorder
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Renal and urinary disorders
Calculus urinary
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Renal and urinary disorders
Dysuria
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Surgical and medical procedures
Glaucoma surgery
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Surgical and medical procedures
Hysterectomy
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Surgical and medical procedures
Tooth extraction
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Vascular disorders
Arteriosclerosis
|
0.56%
2/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Vascular disorders
Hypertension
|
1.1%
4/354 • 15-30 days after final visit (final visit=up to 6 months)
|
1.1%
4/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Vascular disorders
Orthostatic hypotension
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Vascular disorders
Varicose vein
|
0.28%
1/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.00%
0/357 • 15-30 days after final visit (final visit=up to 6 months)
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/354 • 15-30 days after final visit (final visit=up to 6 months)
|
0.28%
1/357 • 15-30 days after final visit (final visit=up to 6 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER