Trial Outcomes & Findings for Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover (NCT NCT01249261)
NCT ID: NCT01249261
Last Updated: 2011-11-02
Results Overview
Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
61 participants
Primary outcome timeframe
Baseline Core Study (Year 1) to Month 6 (Year 8)
Results posted on
2011-11-02
Participant Flow
Screening began 4 October 2001
Patients who sequentially completed Clinical Studies RVE009093 (3 year core study), RVE1996077 Year 4/5 extension study) and RVE1998080 (Year 6/7 extension study) were eligible for screening. \[No NCT numbers available\]
Participant milestones
| Measure |
Placebo/Risedronate
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo/Risedronate
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover
Baseline characteristics by cohort
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
66.9 Participants
STANDARD_DEVIATION 6.24 • n=5 Participants
|
67.3 Participants
STANDARD_DEVIATION 5.79 • n=7 Participants
|
67.1 Participants
STANDARD_DEVIATION 5.97 • n=5 Participants
|
|
Age, Customized
< 65 years old
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Customized
> or = 65 years old
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
30 participants
n=5 Participants
|
31 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 6 (Year 8)Population: ITT Population
Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population
|
6.2217 Percent Change
Standard Error 1.82459
|
12.7784 Percent Change
Standard Error 2.09663
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 12 (Year 8)Population: ITT Population
Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population
|
5.5312 Percent Change
Standard Error 1.66394
|
13.3472 Percent Change
Standard Error 2.09761
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)Population: ITT Population
Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
|
5.5312 Percent Change
Standard Error 1.66394
|
13.3472 Percent Change
Standard Error 2.09761
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 6 (Year 8)Population: ITT Population
Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population
|
-1.0384 Percent Change
Standard Error 2.19722
|
1.4797 Percent Change
Standard Error 1.03811
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 12 (Year 8)Population: ITT Population
Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population
|
-0.2530 Percent Change
Standard Error 1.83321
|
3.2192 Percent Change
Standard Error 3.55882
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)Population: ITT Population
Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
|
-1.1148 Percent Change
Standard Error 1.94506
|
3.2192 Percent Change
Standard Error 3.55882
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 6 (Year 8)Population: ITT Population
Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population
|
1.6386 Percent Change
Standard Error 1.39295
|
4.4060 Percent Change
Standard Error 1.54420
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 12 (Year 8)Population: ITT Population
Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population
|
1.9561 Percent Change
Standard Error 1.37883
|
2.2334 Percent Change
Standard Error 1.37500
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)Population: ITT Population
Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
|
1.4058 Percent Change
Standard Error 1.42232
|
2.2334 Percent Change
Standard Error 1.37500
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 6 (Year 8)Population: ITT Population
Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population
|
-1.3867 Percent Change
Standard Error 1.98837
|
3.3871 Percent Change
Standard Error 0.96971
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 12 (Year 8)Population: ITT Population
Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population
|
-2.2999 Percent Change
Standard Error 1.67680
|
0.6672 Percent Change
Standard Error 0.99708
|
PRIMARY outcome
Timeframe: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)Population: ITT Population
Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Outcome measures
| Measure |
Placebo/Risedronate
n=30 Participants
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 Participants
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
|
-3.2799 Percent Change
Standard Error 1.80579
|
0.6672 Percent Change
Standard Error 0.99708
|
Adverse Events
Placebo/Risedronate
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Risedronate
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Risedronate
n=30 participants at risk
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 participants at risk
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Injury, poisoning and procedural complications
Accidental Injury
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Gastrointestinal disorders
Esophagitis
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
Other adverse events
| Measure |
Placebo/Risedronate
n=30 participants at risk
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
|
Risedronate
n=31 participants at risk
Risedronate 5mg years 1-7, no drug year 8
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
2/30 • Number of events 2 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Nervous system disorders
Depression
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Nervous system disorders
Neurosis
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Nervous system disorders
Sleep Disorder
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Nervous system disorders
Amnesia
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Nervous system disorders
Confusion
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Nervous system disorders
ExtraPyramidal Syndrome
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Nervous system disorders
Hyperkinesia
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Nervous system disorders
Neuralgia
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Nervous system disorders
Paresthesia
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Nervous system disorders
Vertigo
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/30 • Twelve months treatment free period.
|
6.5%
2/31 • Number of events 2 • Twelve months treatment free period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Cardiac disorders
Hypertension
|
6.7%
2/30 • Number of events 2 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Cardiac disorders
Peripheral Vascular Disease
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Cardiac disorders
Coronary Artery Disease
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Cardiac disorders
Heart Failure
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
0.00%
0/30 • Twelve months treatment free period.
|
6.5%
2/31 • Number of events 2 • Twelve months treatment free period.
|
|
Musculoskeletal and connective tissue disorders
Traumatic Bone Fracture
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • Number of events 2 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Musculoskeletal and connective tissue disorders
Arthrosis
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Skin and subcutaneous tissue disorders
Dermatologic Fungus
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/30 • Twelve months treatment free period.
|
6.5%
2/31 • Number of events 2 • Twelve months treatment free period.
|
|
Eye disorders
Amblyopia
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Eye disorders
Glaucoma
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Ear and labyrinth disorders
Vestibular Disorder
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Gastrointestinal disorders
Duodenitis
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Gastrointestinal disorders
Esophagitis
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Gastrointestinal disorders
Increased GGTP (Gamma Glutamyl Transpeptidase)
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Gastrointestinal disorders
Glossitis
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anemia
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
6.7%
2/30 • Number of events 3 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 2 • Twelve months treatment free period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Neoplasm
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Reproductive system and breast disorders
Breast Pain
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.7%
2/30 • Number of events 2 • Twelve months treatment free period.
|
12.9%
4/31 • Number of events 4 • Twelve months treatment free period.
|
|
Infections and infestations
Abscess
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
General disorders
Asthenia
|
0.00%
0/30 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Infections and infestations
Infection
|
10.0%
3/30 • Number of events 4 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Injury, poisoning and procedural complications
Accidental Injury
|
10.0%
3/30 • Number of events 5 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
General disorders
Chest Pain
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
3.2%
1/31 • Number of events 1 • Twelve months treatment free period.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Injury, poisoning and procedural complications
Hernia
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
3.3%
1/30 • Number of events 1 • Twelve months treatment free period.
|
0.00%
0/31 • Twelve months treatment free period.
|
Additional Information
Grexan J. 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