Trial Outcomes & Findings for Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis (NCT NCT00542425)
NCT ID: NCT00542425
Last Updated: 2017-10-30
Results Overview
PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
222 participants
Primary outcome timeframe
6 months
Results posted on
2017-10-30
Participant Flow
Recruitment for the study started in the US, in January 2007. For the initial 24-week treatment period, patients were randomized to study treatment at 30 study centers in the US, Argentina, India and the UK . Eleven of the 30 study centers treated patients in the 24-week treatment extension period in the US, Argentina, and India.
After eligibility was established, patients entered a 4-week Pretreatment Period during which they received daily Calcium and Vitamin D supplements, were trained in self-injection with the pen devices, and were assessed for additional evaluations at the end of the Pretreatment Period. Patients who remained eligible were randomized on Day 1.
Participant milestones
| Measure |
Placebo
|
BA058 20 µg
|
BA058 40 µg
|
BA058 80 µg
|
Teriparatide
|
|---|---|---|---|---|---|
|
Initial 24 Weeks
STARTED
|
46
|
43
|
43
|
45
|
45
|
|
Initial 24 Weeks
COMPLETED
|
42
|
33
|
36
|
34
|
39
|
|
Initial 24 Weeks
NOT COMPLETED
|
4
|
10
|
7
|
11
|
6
|
|
Extended 24 Weeks of Treatment
STARTED
|
11
|
13
|
10
|
7
|
14
|
|
Extended 24 Weeks of Treatment
COMPLETED
|
10
|
11
|
8
|
6
|
13
|
|
Extended 24 Weeks of Treatment
NOT COMPLETED
|
1
|
2
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
|
BA058 20 µg
|
BA058 40 µg
|
BA058 80 µg
|
Teriparatide
|
|---|---|---|---|---|---|
|
Initial 24 Weeks
Administrative reasons
|
0
|
0
|
1
|
1
|
0
|
|
Initial 24 Weeks
Adverse Event
|
0
|
1
|
1
|
3
|
2
|
|
Initial 24 Weeks
Inability to complete procedures
|
0
|
3
|
2
|
1
|
2
|
|
Initial 24 Weeks
Lost to Follow-up
|
2
|
2
|
1
|
0
|
0
|
|
Initial 24 Weeks
Non-compliance
|
0
|
0
|
0
|
1
|
1
|
|
Initial 24 Weeks
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
|
Initial 24 Weeks
Refusal of treatment
|
2
|
2
|
1
|
4
|
1
|
|
Initial 24 Weeks
Other
|
0
|
2
|
1
|
0
|
0
|
|
Extended 24 Weeks of Treatment
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
|
Extended 24 Weeks of Treatment
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
|
Extended 24 Weeks of Treatment
Refusal of treatment
|
0
|
1
|
0
|
0
|
0
|
|
Extended 24 Weeks of Treatment
Other
|
1
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
Baseline characteristics by cohort
| Measure |
Placebo
n=46 Participants
|
BA058 20 µg
n=43 Participants
|
BA058 40 µg
n=43 Participants
|
BA058 80 µg
n=45 Participants
|
Teriparatide
n=45 Participants
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 7.11 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 6.96 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 7.35 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 7.21 • n=4 Participants
|
64.5 years
STANDARD_DEVIATION 7.48 • n=21 Participants
|
65 years
STANDARD_DEVIATION 7.19 • n=10 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
222 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 193 of the 221 ITT patients had data available for analysis at Week 24.
PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.
Outcome measures
| Measure |
Placebo
n=38 Participants
|
BA058 20 µg
n=34 Participants
|
BA058 40 µg
n=37 Participants
|
BA058 80 µg
n=42 Participants
|
Teriparatide
n=42 Participants
|
|---|---|---|---|---|---|
|
Change in Marker of Bone Metabolism, PINP
|
-13.1 Percent change from baseline
Standard Deviation 26.47
|
20.0 Percent change from baseline
Standard Deviation 61.05
|
90.8 Percent change from baseline
Standard Deviation 116.92
|
97.2 Percent change from baseline
Standard Deviation 123.88
|
154.3 Percent change from baseline
Standard Deviation 213.07
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 187 of the 221 ITT patients had data available for analysis at Week 24.
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.
Outcome measures
| Measure |
Placebo
n=42 Participants
|
BA058 20 µg
n=32 Participants
|
BA058 40 µg
n=37 Participants
|
BA058 80 µg
n=36 Participants
|
Teriparatide
n=40 Participants
|
|---|---|---|---|---|---|
|
Change in Bone Mineral Density, Total Spine.
|
1.22 Percent change from baseline
Standard Deviation 3.211
|
3.30 Percent change from baseline
Standard Deviation 2.068
|
5.21 Percent change from baseline
Standard Deviation 4.427
|
6.11 Percent change from baseline
Standard Deviation 3.744
|
5.47 Percent change from baseline
Standard Deviation 4.218
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24.
Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.
Outcome measures
| Measure |
Placebo
n=41 Participants
|
BA058 20 µg
n=31 Participants
|
BA058 40 µg
n=37 Participants
|
BA058 80 µg
n=35 Participants
|
Teriparatide
n=38 Participants
|
|---|---|---|---|---|---|
|
Change in Bone Mineral Density, Femoral Neck.
|
0.79 Percent change from baseline
Standard Deviation 4.797
|
2.69 Percent change from baseline
Standard Deviation 4.022
|
2.20 Percent change from baseline
Standard Deviation 4.406
|
3.07 Percent change from baseline
Standard Deviation 4.175
|
1.07 Percent change from baseline
Standard Deviation 4.564
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24.
Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.
Outcome measures
| Measure |
Placebo
n=41 Participants
|
BA058 20 µg
n=31 Participants
|
BA058 40 µg
n=37 Participants
|
BA058 80 µg
n=35 Participants
|
Teriparatide
n=38 Participants
|
|---|---|---|---|---|---|
|
Change in Bone Mineral Density, Total Hip.
|
0.39 Percent change from baseline
Standard Deviation 3.053
|
1.43 Percent change from baseline
Standard Deviation 2.639
|
1.97 Percent change from baseline
Standard Deviation 3.699
|
2.60 Percent change from baseline
Standard Deviation 3.488
|
0.45 Percent change from baseline
Standard Deviation 3.925
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The extension population included any patient who continued in the extended 24 weeks of treatment; N=55. 49 of the 55 extension patients had data available for analysis at Week 48.
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.
Outcome measures
| Measure |
Placebo
n=10 Participants
|
BA058 20 µg
n=11 Participants
|
BA058 40 µg
n=9 Participants
|
BA058 80 µg
n=6 Participants
|
Teriparatide
n=13 Participants
|
|---|---|---|---|---|---|
|
Change in Bone Mineral Density, Total Spine.
|
0.74 Percent change from baseline
Standard Deviation 3.541
|
5.14 Percent change from baseline
Standard Deviation 3.164
|
9.84 Percent change from baseline
Standard Deviation 5.313
|
12.94 Percent change from baseline
Standard Deviation 3.251
|
8.63 Percent change from baseline
Standard Deviation 6.8
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
BA058 20 µg
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
BA058 40 µg
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
BA058 80 µg
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Teriparatide
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=45 participants at risk
|
BA058 20 µg
n=43 participants at risk
|
BA058 40 µg
n=43 participants at risk
|
BA058 80 µg
n=45 participants at risk
|
Teriparatide
n=45 participants at risk
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.3%
1/43 • Number of events 1 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Bronchitis
|
2.2%
1/45 • Number of events 1 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • Number of events 1 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.3%
1/43 • Number of events 1 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Bilateral crural hernia
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • Number of events 1 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
Other adverse events
| Measure |
Placebo
n=45 participants at risk
|
BA058 20 µg
n=43 participants at risk
|
BA058 40 µg
n=43 participants at risk
|
BA058 80 µg
n=45 participants at risk
|
Teriparatide
n=45 participants at risk
|
|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
6.7%
3/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
7.0%
3/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.3%
1/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.3%
1/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
11.6%
5/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
6.7%
3/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
6.7%
3/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
11.6%
5/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.4%
2/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.4%
2/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
7.0%
3/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.7%
2/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
General disorders
Injection site hematoma
|
11.1%
5/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.7%
2/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
11.6%
5/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
13.3%
6/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
General disorders
Injection site hemorrhage
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
6.7%
3/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Bronchitis
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
7.0%
3/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.7%
2/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
6.7%
3/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.4%
2/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.3%
1/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.7%
2/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
6.7%
3/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Influenza
|
15.6%
7/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.3%
1/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
7.0%
3/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
11.1%
5/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
13.3%
6/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
2/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
11.6%
5/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.7%
2/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
6.7%
3/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
13.3%
6/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.7%
2/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.3%
1/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
6.7%
3/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
9.3%
4/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.3%
1/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
8.9%
4/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.3%
1/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
7.0%
3/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.4%
2/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
8.9%
4/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
9.3%
4/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
4/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.7%
2/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
11.6%
5/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
6.7%
3/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
5/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
7.0%
3/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
14.0%
6/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Headache
|
6.7%
3/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.7%
2/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
14.0%
6/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
13.3%
6/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
13.3%
6/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
7.0%
3/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
2.2%
1/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Hypercalciuria
|
8.9%
4/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
7.0%
3/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.7%
2/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
8.9%
4/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
8.9%
4/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.7%
2/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
7.0%
3/43 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.4%
2/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/45 • For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI/Institution may publish/present results of the Study provided that the Publication is reviewed by the Sponsor for Confidential Information at least 60 days prior to submission. If the Publication contains patent-related information, the submission shall be delayed for 90 days. The Institution/PI will not publish until after the data from the multi-center study is published in a combined paper as long as it is completed within 18 months from the date of study completion.
- Publication restrictions are in place
Restriction type: OTHER