Trial Outcomes & Findings for Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method (NCT NCT00386360)
NCT ID: NCT00386360
Last Updated: 2012-01-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
161 participants
Primary outcome timeframe
Baseline and Month 12
Results posted on
2012-01-11
Participant Flow
Screening started 3 April 2006
Participant milestones
| Measure |
Placebo
Placebo, 1 tablet weekly on the same day
|
Risedronate
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
112
|
|
Overall Study
Intent to Treat Population (ITT)
|
49
|
110
|
|
Overall Study
Primary Efficacy
|
36
|
77
|
|
Overall Study
COMPLETED
|
40
|
95
|
|
Overall Study
NOT COMPLETED
|
9
|
17
|
Reasons for withdrawal
| Measure |
Placebo
Placebo, 1 tablet weekly on the same day
|
Risedronate
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
|
Overall Study
Did not take any study medication
|
0
|
2
|
Baseline Characteristics
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
Baseline characteristics by cohort
| Measure |
Placebo
n=49 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=112 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
52.5 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
161 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
Asian (Oriental)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
48 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
9 participants
n=5 Participants
|
24 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
23 participants
n=5 Participants
|
46 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
6 participants
n=5 Participants
|
15 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: Primary Efficacy Population - all patients in ITT population who had no major protocol violations and had an evaluable distal radius BV/TV (trabecular bone volume to tissue volume) at baseline and Month 12.
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=110 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12
|
-1.486 Percent Change
Interval -2.577 to -0.396
|
-1.255 Percent Change
Interval -2.012 to -0.498
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Per Protocol (PP) Population - all patients in ITT population who had no major protocol violations.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12
|
-2.121 Percent Change
Interval -3.028 to -1.214
|
-1.578 Percent Change
Interval -2.208 to -0.947
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12
|
-0.786 Percent Change
Interval -1.337 to -0.234
|
-0.301 Percent Change
Interval -0.685 to 0.082
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12
|
-1.820 Percent Change
Interval -3.02 to -0.619
|
-1.156 Percent Change
Interval -1.991 to -0.321
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
|
-0.440 Percent Change
Interval -1.221 to 0.34
|
-0.106 Percent Change
Interval -0.652 to 0.439
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
|
-0.784 Percent Change
Interval -1.349 to -0.219
|
-0.173 Percent Change
Interval -0.568 to 0.222
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
|
0.785 Percent Change
Interval -0.272 to 1.841
|
0.725 Percent Change
Interval -0.014 to 1.463
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Lumbar Spine BMD, Percent Change From Baseline to Month 12
|
-1.797 Percent Change
Interval -2.714 to -0.881
|
1.473 Percent Change
Interval 0.839 to 2.106
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12
|
-0.976 Percent Change
Interval -1.59 to -0.363
|
0.468 Percent Change
Interval 0.043 to 0.892
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Femoral Neck BMD, Percent Change From Baseline to Month 12
|
-1.422 Percent Change
Interval -2.25 to -0.595
|
-0.014 Percent Change
Interval -0.586 to 0.558
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Greater Trochanter BMD, Percent Change From Baseline to Month 12
|
-0.462 Percent Change
Interval -1.417 to 0.492
|
0.996 Percent Change
Interval 0.336 to 1.656
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
ELISA / enzyme-linked immunosorbent assay method by central lab
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12
|
1.537 Percent Change
Interval -16.458 to 19.533
|
-38.002 Percent Change
Interval -50.446 to -25.559
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
Electrochemiluminescence assay method by central lab
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12
|
-5.762 Percent Change
Interval -15.47 to 3.946
|
-46.031 Percent Change
Interval -52.785 to -39.277
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: PP - all patients in ITT population who had no major protocol violations.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=89 Participants
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Height, Percent Change From Baseline to Month 12
|
-0.163 Percent Change
Interval -0.27 to -0.056
|
-0.071 Percent Change
Interval -0.146 to 0.003
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 38 other events
Deaths: 0 deaths
Risedronate
Serious events: 7 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=49 participants at risk
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=110 participants at risk
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/49 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Injury, poisoning and procedural complications
Skeletal Injury
|
0.00%
0/49 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/49 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/49 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Infections and infestations
Cholera
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Infections and infestations
Vestibuar Neuronitis
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Nervous system disorders
Cervical Root Pain
|
0.00%
0/49 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Psychiatric disorders
Depression
|
0.00%
0/49 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Psychiatric disorders
Panic Reaction
|
0.00%
0/49 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Renal and urinary disorders
Urinary Bladder Polyp
|
0.00%
0/49 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Ear and labyrinth disorders
Vertigo Positional
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
Other adverse events
| Measure |
Placebo
n=49 participants at risk
Placebo, 1 tablet weekly on the same day
|
Risedronate
n=110 participants at risk
35 mg risedronate tablet, orally, once weekly on the same day
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.2%
5/49 • Number of events 5 • Twelve Months
|
9.1%
10/110 • Number of events 11 • Twelve Months
|
|
Infections and infestations
Bronchitis
|
6.1%
3/49 • Number of events 3 • Twelve Months
|
6.4%
7/110 • Number of events 7 • Twelve Months
|
|
Infections and infestations
Gastroenteritis
|
4.1%
2/49 • Number of events 2 • Twelve Months
|
3.6%
4/110 • Number of events 4 • Twelve Months
|
|
Infections and infestations
Influenza
|
8.2%
4/49 • Number of events 4 • Twelve Months
|
3.6%
4/110 • Number of events 4 • Twelve Months
|
|
Infections and infestations
Cholera
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Infections and infestations
Tonsillitis
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Infections and infestations
Vestibular Neuronitis
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
3.6%
4/110 • Number of events 4 • Twelve Months
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/49 • Twelve Months
|
3.6%
4/110 • Number of events 4 • Twelve Months
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
2.7%
3/110 • Number of events 3 • Twelve Months
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/49 • Twelve Months
|
2.7%
3/110 • Number of events 3 • Twelve Months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/49 • Twelve Months
|
2.7%
3/110 • Number of events 4 • Twelve Months
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
1.8%
2/110 • Number of events 2 • Twelve Months
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
2/49 • Number of events 2 • Twelve Months
|
0.91%
1/110 • Number of events 2 • Twelve Months
|
|
Gastrointestinal disorders
Gastritis
|
4.1%
2/49 • Number of events 2 • Twelve Months
|
0.91%
1/110 • Number of events 2 • Twelve Months
|
|
Gastrointestinal disorders
Glossodynia
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
2/49 • Number of events 2 • Twelve Months
|
7.3%
8/110 • Number of events 11 • Twelve Months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.2%
5/49 • Number of events 5 • Twelve Months
|
2.7%
3/110 • Number of events 4 • Twelve Months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
2.7%
3/110 • Number of events 3 • Twelve Months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/49 • Twelve Months
|
2.7%
3/110 • Number of events 3 • Twelve Months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.1%
3/49 • Number of events 3 • Twelve Months
|
2.7%
3/110 • Number of events 3 • Twelve Months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
4.1%
2/49 • Number of events 2 • Twelve Months
|
1.8%
2/110 • Number of events 2 • Twelve Months
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
2.0%
1/49 • Number of events 2 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/49 • Twelve Months
|
3.6%
4/110 • Number of events 4 • Twelve Months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/49 • Twelve Months
|
2.7%
3/110 • Number of events 3 • Twelve Months
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Injury, poisoning and procedural complications
Back Injury
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Injury, poisoning and procedural complications
Limb Injury
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Vascular disorders
Hypertension
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
4.5%
5/110 • Number of events 5 • Twelve Months
|
|
Vascular disorders
Hot Flush
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
2.7%
3/110 • Number of events 3 • Twelve Months
|
|
Nervous system disorders
Headache
|
4.1%
2/49 • Number of events 2 • Twelve Months
|
2.7%
3/110 • Number of events 3 • Twelve Months
|
|
Nervous system disorders
Cervicobrachial Syndrome
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/49 • Number of events 2 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
General disorders
Drug Intolerance
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
General disorders
Irritability
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
General disorders
Oedema Peripheral
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
General disorders
Sensation of Foreign Body
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
General disorders
Temperature Intolerance
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Reproductive system and breast disorders
Endometriosis
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Reproductive system and breast disorders
Vulvovaginal Dryness
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Skin and subcutaneous tissue disorders
Onchoclasis
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/49 • Twelve Months
|
2.7%
3/110 • Number of events 4 • Twelve Months
|
|
Investigations
Weight Decreased
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Investigations
Weight Increased
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.91%
1/110 • Number of events 1 • Twelve Months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Cardiac disorders
Angina
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Psychiatric disorders
Depression
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
1.8%
2/110 • Number of events 2 • Twelve Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Ear and labyrinth disorders
Ear Pain
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
|
Ear and labyrinth disorders
Vertigo Positional
|
2.0%
1/49 • Number of events 1 • Twelve Months
|
0.00%
0/110 • Twelve Months
|
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