Trial Outcomes & Findings for A Study of Monthly Risedronate for Osteoporosis (NCT NCT00247273)
NCT ID: NCT00247273
Last Updated: 2013-04-22
Results Overview
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1294 participants
Primary outcome timeframe
Baseline to Month 12 - Endpoint
Results posted on
2013-04-22
Participant Flow
Screening period began 17 Oct '05
Participant milestones
| Measure |
5 mg Risedronate
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Overall Study
STARTED
|
644
|
650
|
|
Overall Study
Intent to Treat Population
|
642
|
650
|
|
Overall Study
COMPLETED
|
498
|
513
|
|
Overall Study
NOT COMPLETED
|
146
|
137
|
Reasons for withdrawal
| Measure |
5 mg Risedronate
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Overall Study
Adverse Event
|
85
|
80
|
|
Overall Study
Physician Decision
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
|
Overall Study
Withdrawal by Subject
|
46
|
47
|
|
Overall Study
Did not take any study drug
|
2
|
0
|
Baseline Characteristics
A Study of Monthly Risedronate for Osteoporosis
Baseline characteristics by cohort
| Measure |
5 mg Risedronate
n=644 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
Total
n=1294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64.4 years
STANDARD_DEVIATION 7.7 • n=39 Participants
|
65.5 years
STANDARD_DEVIATION 7.2 • n=41 Participants
|
64.9 years
STANDARD_DEVIATION 7.5 • n=35 Participants
|
|
Age, Customized
< 65 years
|
335 Partcipants
n=39 Participants
|
304 Partcipants
n=41 Participants
|
639 Partcipants
n=35 Participants
|
|
Age, Customized
65 - <75 years
|
232 Partcipants
n=39 Participants
|
268 Partcipants
n=41 Participants
|
500 Partcipants
n=35 Participants
|
|
Age, Customized
> = 75 years
|
75 Partcipants
n=39 Participants
|
78 Partcipants
n=41 Participants
|
153 Partcipants
n=35 Participants
|
|
Sex: Female, Male
Female
|
644 Participants
n=39 Participants
|
650 Participants
n=41 Participants
|
1294 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Argentina
|
302 participants
n=39 Participants
|
304 participants
n=41 Participants
|
606 participants
n=35 Participants
|
|
Region of Enrollment
Australia
|
7 participants
n=39 Participants
|
7 participants
n=41 Participants
|
14 participants
n=35 Participants
|
|
Region of Enrollment
Belgium
|
13 participants
n=39 Participants
|
14 participants
n=41 Participants
|
27 participants
n=35 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=39 Participants
|
19 participants
n=41 Participants
|
38 participants
n=35 Participants
|
|
Region of Enrollment
Spain
|
7 participants
n=39 Participants
|
9 participants
n=41 Participants
|
16 participants
n=35 Participants
|
|
Region of Enrollment
Estonia
|
48 participants
n=39 Participants
|
50 participants
n=41 Participants
|
98 participants
n=35 Participants
|
|
Region of Enrollment
Finland
|
17 participants
n=39 Participants
|
18 participants
n=41 Participants
|
35 participants
n=35 Participants
|
|
Region of Enrollment
France
|
50 participants
n=39 Participants
|
49 participants
n=41 Participants
|
99 participants
n=35 Participants
|
|
Region of Enrollment
Hungary
|
22 participants
n=39 Participants
|
22 participants
n=41 Participants
|
44 participants
n=35 Participants
|
|
Region of Enrollment
Lebanon
|
6 participants
n=39 Participants
|
6 participants
n=41 Participants
|
12 participants
n=35 Participants
|
|
Region of Enrollment
Norway
|
24 participants
n=39 Participants
|
25 participants
n=41 Participants
|
49 participants
n=35 Participants
|
|
Region of Enrollment
Poland
|
103 participants
n=39 Participants
|
104 participants
n=41 Participants
|
207 participants
n=35 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=39 Participants
|
23 participants
n=41 Participants
|
47 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12 - EndpointPopulation: ITT (intent to treat) Population
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
|
3.425 Percent Change
Interval 3.028 to 3.823
|
3.540 Percent Change
Interval 3.147 to 3.934
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT Population
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
|
3.522 Percent Change
Interval 3.116 to 3.928
|
3.598 Percent Change
Interval 3.201 to 3.995
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
|
0.0256 g/cm^2
Interval 0.0226 to 0.0286
|
0.0261 g/cm^2
Interval 0.0232 to 0.0291
|
SECONDARY outcome
Timeframe: Baseline to Month 24 - EndpointPopulation: ITT Population
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)
|
3.927 Percent Change
Interval 3.432 to 4.422
|
4.166 Percent Change
Interval 3.677 to 4.654
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
|
4.217 Percent Change
Interval 3.685 to 4.75
|
4.302 Percent Change
Interval 3.783 to 4.822
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
|
0.0309 g/cm^2
Interval 0.027 to 0.0349
|
0.0319 g/cm^2
Interval 0.028 to 0.0357
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population
|
-30.04 nmol BCE / mmol Creatinine
Interval -33.19 to -26.88
|
-30.26 nmol BCE / mmol Creatinine
Interval -33.41 to -27.12
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24.
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population
|
-51.83 Percent Change
Interval -54.83 to -48.83
|
-50.26 Percent Change
Interval -53.25 to -47.27
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24.
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
|
-28.88 nmol BCE / mmol Creatinine
Interval -32.5 to -25.26
|
-29.87 nmol BCE / mmol Creatinine
Interval -33.38 to -26.37
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24.
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
|
-49.45 Percent Change
Interval -53.16 to -45.74
|
-46.62 Percent Change
Interval -50.21 to -43.03
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT
ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population
|
-0.36 ng / mL
Interval -0.39 to -0.33
|
-0.34 ng / mL
Interval -0.37 to -0.31
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT
Assayed by electrochemiluminescent immunoassay.
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Serum CTX at Month 6, ITT Population
|
-57.79 Percent Change
Interval -61.73 to -53.84
|
-53.62 Percent Change
Interval -57.54 to -49.69
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT
Assayed by electrochemiluminescent immunoassay.
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Change From Baseline in Serum CTX at Month 24, ITT Population
|
-0.22 ng / mL
Interval -0.26 to -0.19
|
-0.20 ng / mL
Interval -0.23 to -0.17
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT
Assayed by electrochemiluminescent immunoassay.
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Serum CTX at Month 24, ITT Population
|
-29.33 Percent Change
Interval -35.82 to -22.84
|
-23.63 Percent Change
Interval -29.94 to -17.33
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT
ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population
|
-5.31 ug / L
Interval -5.79 to -4.83
|
-5.48 ug / L
Interval -5.96 to -5.0
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT
Assayed by ELISA (enzyme-linked immunosorbent assay)
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Serum BAP at Month 6, ITT Population
|
-33.34 Percent Change
Interval -35.58 to -31.11
|
-34.66 Percent Change
Interval -36.88 to -32.43
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT
Assayed by ELISA (enzyme-linked immunosorbent assay)
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Change From Baseline in Serum BAP at Month 24, ITT Population
|
-4.10 ug / L
Interval -4.69 to -3.52
|
-4.22 ug / L
Interval -4.79 to -3.65
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT
Assayed by ELISA (enzyme-linked immunosorbent assay)
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Serum BAP at Month 24, ITT Population
|
-25.84 Percent Change
Interval -29.1 to -22.57
|
-25.07 Percent Change
Interval -28.25 to -21.9
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT
At least 1 new fractured vertebra
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Number of Participants With New Vertebral Fracture at Month 12, ITT Population
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT
At least 1 new fractured vertebra
Outcome measures
| Measure |
5 mg Risedronate
n=642 Participants
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 Participants
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Number of Participants With New Vertebral Fracture at Month 24, ITT Population
|
14 Participants
|
14 Participants
|
Adverse Events
5 mg Risedronate
Serious events: 51 serious events
Other events: 554 other events
Deaths: 0 deaths
150 mg Risedronate
Serious events: 77 serious events
Other events: 578 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg Risedronate
n=642 participants at risk
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 participants at risk
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Cardiac disorders
Myocardial Ischaemia
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.46%
3/650 • Number of events 3 • 17 Oct '05 thru 18 Mar '08
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.31%
2/650 • Number of events 3 • 17 Oct '05 thru 18 Mar '08
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.31%
2/650 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
|
Cardiac disorders
Angina Pectoris
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Cardiac disorders
Myocardial Infarction
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Cardiac disorders
Atrial Fibrillation
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.46%
3/650 • Number of events 4 • 17 Oct '05 thru 18 Mar '08
|
|
Cardiac disorders
Congestive Cardiomyopathy
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Cardiac disorders
Hypertrophic Cardiomyopathy
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Cardiac disorders
Coronary Artery Disease
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.16%
1/642 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Cardiac disorders
Cardiac Failure
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Cardiac disorders
Cardiac Arrest
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.31%
2/642 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
0.46%
3/650 • Number of events 3 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Syncope
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.31%
2/650 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Dementia Alzheimer's Type
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Facial Palsy
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Sciatica
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Cubital Tunnel Syndrome
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Presyncope
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Parkinson's Disease
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.47%
3/642 • Number of events 3 • 17 Oct '05 thru 18 Mar '08
|
1.1%
7/650 • Number of events 7 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Thyroid Gland
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Adenoma
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of Breast
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar Tumor
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma Stage II
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid Tumour Benign
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Lymph Nodes
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma Stage Unspecified
|
0.31%
2/642 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.31%
2/650 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Pneumonia
|
0.78%
5/642 • Number of events 6 • 17 Oct '05 thru 18 Mar '08
|
0.31%
2/650 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Bronchitis
|
0.31%
2/642 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.31%
2/650 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Postoperative Abscess
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Gastroenteritis
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Toxoplasmosis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Pharyngolaryngeal abscess
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Filariasis
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Erysipelas
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Lymphangitis
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.31%
2/650 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.31%
2/642 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Fall
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.31%
2/650 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Diarrhoea
|
0.16%
1/642 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Erosive Duodenitis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Adbominal Pain Upper
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Intestinal Prolapse
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Subileus
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Cholelithiasis
|
0.31%
2/642 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
0.62%
4/650 • Number of events 4 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Hepatic Cyst
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Cholangitis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Bile Duct Stone
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Eosinophilic Fasciitis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.31%
2/650 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
|
Reproductive system and breast disorders
Colpocele
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Reproductive system and breast disorders
Rectocele
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Reproductive system and breast disorders
Cystocele
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.46%
3/650 • Number of events 3 • 17 Oct '05 thru 18 Mar '08
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic Crisis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Vascular disorders
Hypertensive Emergency
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Vascular disorders
Aortic Dilatation
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Vascular disorders
Varicose Vein
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Vascular disorders
Cardiovascular Insufficiency
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Renal and urinary disorders
Bladder Prolapse
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Renal and urinary disorders
Haematuria
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Renal and urinary disorders
Calculus Urinary
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 2 • 17 Oct '05 thru 18 Mar '08
|
|
General disorders
Chest Pain
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
General disorders
Death
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Metabolism and nutrition disorders
Dehydration
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/642 • 17 Oct '05 thru 18 Mar '08
|
0.15%
1/650 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
|
Eye disorders
Blindness
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Eye disorders
Cataract
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Immune system disorders
Drug Hypersensitivity
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.16%
1/642 • Number of events 1 • 17 Oct '05 thru 18 Mar '08
|
0.00%
0/650 • 17 Oct '05 thru 18 Mar '08
|
Other adverse events
| Measure |
5 mg Risedronate
n=642 participants at risk
5 mg risedronate tablet, once daily for 2 years
|
150 mg Risedronate
n=650 participants at risk
150 mg risedronate taken once a month for 2 years
|
|---|---|---|
|
Infections and infestations
Influenza
|
8.9%
57/642 • Number of events 62 • 17 Oct '05 thru 18 Mar '08
|
14.5%
94/650 • Number of events 112 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Nasopharyngitis
|
9.7%
62/642 • Number of events 76 • 17 Oct '05 thru 18 Mar '08
|
10.8%
70/650 • Number of events 86 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Urinary Tract Infection
|
7.8%
50/642 • Number of events 58 • 17 Oct '05 thru 18 Mar '08
|
9.4%
61/650 • Number of events 83 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Bronchitis
|
10.6%
68/642 • Number of events 76 • 17 Oct '05 thru 18 Mar '08
|
8.8%
57/650 • Number of events 74 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Diarrrhoea
|
6.7%
43/642 • Number of events 49 • 17 Oct '05 thru 18 Mar '08
|
10.6%
69/650 • Number of events 95 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.9%
51/642 • Number of events 65 • 17 Oct '05 thru 18 Mar '08
|
9.5%
62/650 • Number of events 74 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Nausea
|
8.1%
52/642 • Number of events 61 • 17 Oct '05 thru 18 Mar '08
|
7.2%
47/650 • Number of events 56 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
37/642 • Number of events 41 • 17 Oct '05 thru 18 Mar '08
|
6.8%
44/650 • Number of events 52 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Constipation
|
8.3%
53/642 • Number of events 56 • 17 Oct '05 thru 18 Mar '08
|
6.6%
43/650 • Number of events 52 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
32/642 • Number of events 36 • 17 Oct '05 thru 18 Mar '08
|
5.5%
36/650 • Number of events 41 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
68/642 • Number of events 81 • 17 Oct '05 thru 18 Mar '08
|
10.0%
65/650 • Number of events 76 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
80/642 • Number of events 87 • 17 Oct '05 thru 18 Mar '08
|
10.0%
65/650 • Number of events 73 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.5%
35/642 • Number of events 37 • 17 Oct '05 thru 18 Mar '08
|
6.9%
45/650 • Number of events 50 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Headache
|
5.9%
38/642 • Number of events 51 • 17 Oct '05 thru 18 Mar '08
|
5.4%
35/650 • Number of events 37 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Fall
|
7.0%
45/642 • Number of events 57 • 17 Oct '05 thru 18 Mar '08
|
8.8%
57/650 • Number of events 66 • 17 Oct '05 thru 18 Mar '08
|
|
Vascular disorders
Hypertension
|
7.6%
49/642 • Number of events 53 • 17 Oct '05 thru 18 Mar '08
|
8.0%
52/650 • Number of events 55 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Gastroenteritis
|
3.3%
21/642 • Number of events 24 • 17 Oct '05 thru 18 Mar '08
|
3.7%
24/650 • Number of events 25 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.7%
11/642 • Number of events 12 • 17 Oct '05 thru 18 Mar '08
|
2.8%
18/650 • Number of events 24 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Pneumonia
|
1.1%
7/642 • Number of events 10 • 17 Oct '05 thru 18 Mar '08
|
2.0%
13/650 • Number of events 13 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Tooth Infection
|
2.0%
13/642 • Number of events 14 • 17 Oct '05 thru 18 Mar '08
|
1.7%
11/650 • Number of events 16 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Cystitis
|
3.0%
19/642 • Number of events 22 • 17 Oct '05 thru 18 Mar '08
|
1.5%
10/650 • Number of events 11 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Sinusitis
|
2.3%
15/642 • Number of events 15 • 17 Oct '05 thru 18 Mar '08
|
1.5%
10/650 • Number of events 10 • 17 Oct '05 thru 18 Mar '08
|
|
Infections and infestations
Pharyngitis
|
2.2%
14/642 • Number of events 15 • 17 Oct '05 thru 18 Mar '08
|
1.4%
9/650 • Number of events 10 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
32/642 • Number of events 36 • 17 Oct '05 thru 18 Mar '08
|
4.8%
31/650 • Number of events 48 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Gastritis
|
3.0%
19/642 • Number of events 21 • 17 Oct '05 thru 18 Mar '08
|
3.7%
24/650 • Number of events 26 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Abdominal Distention
|
2.5%
16/642 • Number of events 18 • 17 Oct '05 thru 18 Mar '08
|
2.9%
19/650 • Number of events 24 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Flatulence
|
3.0%
19/642 • Number of events 19 • 17 Oct '05 thru 18 Mar '08
|
2.8%
18/650 • Number of events 21 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.62%
4/642 • Number of events 4 • 17 Oct '05 thru 18 Mar '08
|
2.8%
18/650 • Number of events 18 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
2.0%
13/642 • Number of events 14 • 17 Oct '05 thru 18 Mar '08
|
1.7%
11/650 • Number of events 11 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Hiatus Hernia
|
3.1%
20/642 • Number of events 20 • 17 Oct '05 thru 18 Mar '08
|
1.2%
8/650 • Number of events 8 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Gastritis erosive
|
2.2%
14/642 • Number of events 15 • 17 Oct '05 thru 18 Mar '08
|
1.1%
7/650 • Number of events 7 • 17 Oct '05 thru 18 Mar '08
|
|
Gastrointestinal disorders
Dry Mouth
|
2.0%
13/642 • Number of events 13 • 17 Oct '05 thru 18 Mar '08
|
0.46%
3/650 • Number of events 3 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.7%
24/642 • Number of events 28 • 17 Oct '05 thru 18 Mar '08
|
4.5%
29/650 • Number of events 31 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.2%
14/642 • Number of events 15 • 17 Oct '05 thru 18 Mar '08
|
3.4%
22/650 • Number of events 23 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.1%
20/642 • Number of events 21 • 17 Oct '05 thru 18 Mar '08
|
3.1%
20/650 • Number of events 22 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
12/642 • Number of events 13 • 17 Oct '05 thru 18 Mar '08
|
2.6%
17/650 • Number of events 19 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.5%
16/642 • Number of events 17 • 17 Oct '05 thru 18 Mar '08
|
2.5%
16/650 • Number of events 16 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.0%
19/642 • Number of events 20 • 17 Oct '05 thru 18 Mar '08
|
2.3%
15/650 • Number of events 15 • 17 Oct '05 thru 18 Mar '08
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
2.2%
14/642 • Number of events 14 • 17 Oct '05 thru 18 Mar '08
|
0.92%
6/650 • Number of events 6 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Dizziness
|
2.6%
17/642 • Number of events 20 • 17 Oct '05 thru 18 Mar '08
|
4.0%
26/650 • Number of events 27 • 17 Oct '05 thru 18 Mar '08
|
|
Nervous system disorders
Sciatica
|
1.7%
11/642 • Number of events 12 • 17 Oct '05 thru 18 Mar '08
|
2.6%
17/650 • Number of events 19 • 17 Oct '05 thru 18 Mar '08
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
19/642 • Number of events 26 • 17 Oct '05 thru 18 Mar '08
|
2.6%
17/650 • Number of events 24 • 17 Oct '05 thru 18 Mar '08
|
|
General disorders
Asthenia
|
2.8%
18/642 • Number of events 19 • 17 Oct '05 thru 18 Mar '08
|
3.5%
23/650 • Number of events 24 • 17 Oct '05 thru 18 Mar '08
|
|
General disorders
Chest Pain
|
1.7%
11/642 • Number of events 11 • 17 Oct '05 thru 18 Mar '08
|
3.2%
21/650 • Number of events 21 • 17 Oct '05 thru 18 Mar '08
|
|
General disorders
Oedema Peripheral
|
1.6%
10/642 • Number of events 11 • 17 Oct '05 thru 18 Mar '08
|
2.2%
14/650 • Number of events 14 • 17 Oct '05 thru 18 Mar '08
|
|
General disorders
Pyrexia
|
1.2%
8/642 • Number of events 9 • 17 Oct '05 thru 18 Mar '08
|
2.0%
13/650 • Number of events 25 • 17 Oct '05 thru 18 Mar '08
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
20/642 • Number of events 22 • 17 Oct '05 thru 18 Mar '08
|
3.7%
24/650 • Number of events 25 • 17 Oct '05 thru 18 Mar '08
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.1%
7/642 • Number of events 7 • 17 Oct '05 thru 18 Mar '08
|
2.2%
14/650 • Number of events 16 • 17 Oct '05 thru 18 Mar '08
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
19/642 • Number of events 22 • 17 Oct '05 thru 18 Mar '08
|
1.5%
10/650 • Number of events 14 • 17 Oct '05 thru 18 Mar '08
|
|
Psychiatric disorders
Depression
|
3.0%
19/642 • Number of events 19 • 17 Oct '05 thru 18 Mar '08
|
3.1%
20/650 • Number of events 21 • 17 Oct '05 thru 18 Mar '08
|
|
Psychiatric disorders
Anxiety
|
2.0%
13/642 • Number of events 13 • 17 Oct '05 thru 18 Mar '08
|
2.8%
18/650 • Number of events 18 • 17 Oct '05 thru 18 Mar '08
|
|
Psychiatric disorders
Insomnia
|
2.5%
16/642 • Number of events 16 • 17 Oct '05 thru 18 Mar '08
|
1.4%
9/650 • Number of events 9 • 17 Oct '05 thru 18 Mar '08
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.9%
12/642 • Number of events 12 • 17 Oct '05 thru 18 Mar '08
|
3.4%
22/650 • Number of events 22 • 17 Oct '05 thru 18 Mar '08
|
|
Eye disorders
Cataract
|
1.9%
12/642 • Number of events 13 • 17 Oct '05 thru 18 Mar '08
|
2.5%
16/650 • Number of events 19 • 17 Oct '05 thru 18 Mar '08
|
|
Eye disorders
Conjunctivitis
|
0.93%
6/642 • Number of events 6 • 17 Oct '05 thru 18 Mar '08
|
2.0%
13/650 • Number of events 13 • 17 Oct '05 thru 18 Mar '08
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
9/642 • Number of events 11 • 17 Oct '05 thru 18 Mar '08
|
2.6%
17/650 • Number of events 19 • 17 Oct '05 thru 18 Mar '08
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Phone: 973-442-3376
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60