Trial Outcomes & Findings for An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia (NCT NCT01571596)
NCT ID: NCT01571596
Last Updated: 2024-06-18
Results Overview
Safety and efficacy of repeated SC injections of KRN23, from Baseline, as assessed by serum phosphorus levels, immunogenicity, adverse events and clinically significant changes in vital signs and laboratory testing.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
13.5 months,(50 visits)
Results posted on
2024-06-18
Participant Flow
Participant milestones
| Measure |
KRN23
Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
|
Bone Substudy KRN23
A Bone substudy in eligible subjects will evaluate the effects of KRN23 on various bone parameters. Subjects will undergo clinical assessments, inclusive of DXA and pQCT at Visits 17 and 33 (prior to dosing), and the end-of-study visit, Visit 49. A subset of subjects will have a bone biopsy of the iliac crest at Visit 33.
|
Bone Substudy Placebo
A Bone substudy in eligible subjects will evaluate the effects of KRN23 on various bone parameters. Subjects will undergo clinical assessments, inclusive of DXA and pQCT at Visits 17 and 33 (prior to dosing), and the end-of-study visit, Visit 49. A subset of subjects will have a bone biopsy of the iliac crest at Visit 33.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
1
|
1
|
|
Overall Study
COMPLETED
|
19
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
KRN23
Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
|
Bone Substudy KRN23
A Bone substudy in eligible subjects will evaluate the effects of KRN23 on various bone parameters. Subjects will undergo clinical assessments, inclusive of DXA and pQCT at Visits 17 and 33 (prior to dosing), and the end-of-study visit, Visit 49. A subset of subjects will have a bone biopsy of the iliac crest at Visit 33.
|
Bone Substudy Placebo
A Bone substudy in eligible subjects will evaluate the effects of KRN23 on various bone parameters. Subjects will undergo clinical assessments, inclusive of DXA and pQCT at Visits 17 and 33 (prior to dosing), and the end-of-study visit, Visit 49. A subset of subjects will have a bone biopsy of the iliac crest at Visit 33.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Study Terminated by the Sponsor
|
0
|
1
|
1
|
Baseline Characteristics
An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
Baseline characteristics by cohort
| Measure |
KRN23
n=21 Participants
Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
|
Bone Substudy KRN23
n=1 Participants
|
Bone Substudy Placebo
n=1 Participants
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
43.0 years
n=5 Participants
|
22 years
n=7 Participants
|
28 years
n=5 Participants
|
41.1 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
20 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American/African Caribbean
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
21 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 13.5 months,(50 visits)Safety and efficacy of repeated SC injections of KRN23, from Baseline, as assessed by serum phosphorus levels, immunogenicity, adverse events and clinically significant changes in vital signs and laboratory testing.
Outcome measures
| Measure |
KRN23
n=21 Participants
Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
|
Bone Substudy KRN23
n=1 Participants
|
Bone Substudy Placebo
n=1 Participants
|
|---|---|---|---|
|
Safety and Efficacy of Repeated SC Injections of KRN23.
With Any TEAE
|
21 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Efficacy of Repeated SC Injections of KRN23.
With Any Drug-related TEAE
|
13 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Efficacy of Repeated SC Injections of KRN23.
With Any TEAE with an Outcome of Death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Efficacy of Repeated SC Injections of KRN23.
With Any Serious TEAE
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Efficacy of Repeated SC Injections of KRN23.
With Any Drug-related Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Efficacy of Repeated SC Injections of KRN23.
With Any Serious TEAE with an Outcome of Death
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 13.5 months, (50 visits)Population: Efficacy analysis set: All subjects who received at least 1 dose of KRN23 and completed at least one 28-day post-dose evaluation.
Effect of repeated SC injections of KRN23, from baseline, on pharmacodynamic parameters (serum phosphorus)
Outcome measures
| Measure |
KRN23
n=22 Participants
Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
|
Bone Substudy KRN23
|
Bone Substudy Placebo
|
|---|---|---|---|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Baseline
|
1.85 mg/dL
Interval 1.2 to 2.3
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 1 /0
|
1.88 mg/dL
Interval 1.3 to 2.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 2 /7
|
2.86 mg/dL
Interval 2.1 to 3.6
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 3 /14
|
2.87 mg/dL
Interval 2.0 to 3.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 4 /25
|
2.48 mg/dL
Interval 2.0 to 3.0
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 5 /0
|
2.25 mg/dL
Interval 1.8 to 3.1
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 6 /7
|
2.91 mg/dL
Interval 2.1 to 3.9
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 7 /14
|
2.95 mg/dL
Interval 2.3 to 3.8
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 8 /25
|
2.67 mg/dL
Interval 1.9 to 3.3
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 9 /0
|
2.43 mg/dL
Interval 1.6 to 2.9
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 10 /7
|
2.96 mg/dL
Interval 2.2 to 3.8
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 11 /14
|
2.84 mg/dL
Interval 2.2 to 3.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 12 /25
|
2.59 mg/dL
Interval 2.1 to 3.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 13 /0
|
2.42 mg/dL
Interval 1.7 to 3.1
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 14 /7
|
2.92 mg/dL
Interval 1.9 to 3.8
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 15 /14
|
2.90 mg/dL
Interval 2.1 to 3.6
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 16 /25
|
2.57 mg/dL
Interval 1.9 to 3.4
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 17 /0
|
2.35 mg/dL
Interval 1.7 to 3.4
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 18 /7
|
2.82 mg/dL
Interval 2.1 to 3.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 19 /14
|
2.74 mg/dL
Interval 2.0 to 3.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 20 /25
|
2.60 mg/dL
Interval 1.8 to 3.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 21 /0
|
2.35 mg/dL
Interval 1.7 to 3.0
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 22 /7
|
2.94 mg/dL
Interval 2.3 to 3.8
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 23 /14
|
2.93 mg/dL
Interval 2.0 to 3.8
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 24 /25
|
2.60 mg/dL
Interval 1.8 to 3.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 25 /0
|
2.37 mg/dL
Interval 1.8 to 2.9
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 26 /7
|
2.83 mg/dL
Interval 2.3 to 3.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 27 /14
|
2.79 mg/dL
Interval 2.1 to 3.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 28 /25
|
2.59 mg/dL
Interval 2.1 to 3.2
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 29 /0
|
2.41 mg/dL
Interval 1.7 to 3.4
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 30 /7
|
2.87 mg/dL
Interval 2.1 to 3.7
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 31 /14
|
2.81 mg/dL
Interval 1.9 to 3.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 32 /25
|
2.55 mg/dL
Interval 2.0 to 3.4
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 33 /0
|
2.42 mg/dL
Interval 1.6 to 3.2
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 34 /7
|
2.79 mg/dL
Interval 2.0 to 3.8
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 35 /14
|
2.75 mg/dL
Interval 1.7 to 3.4
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 36 /25
|
2.53 mg/dL
Interval 1.9 to 3.6
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 37 /0
|
2.52 mg/dL
Interval 1.9 to 3.4
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 38 /7
|
2.85 mg/dL
Interval 1.9 to 3.9
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 39 /14
|
2.69 mg/dL
Interval 1.7 to 3.7
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 40 /25
|
2.48 mg/dL
Interval 1.8 to 3.5
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 41 /0
|
2.29 mg/dL
Interval 1.8 to 3.2
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 42 /7
|
2.71 mg/dL
Interval 1.7 to 3.8
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 43 /14
|
2.70 mg/dL
Interval 2.0 to 3.6
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 44 /25
|
2.43 mg/dL
Interval 1.9 to 2.9
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 45 /0
|
2.25 mg/dL
Interval 1.7 to 2.8
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 46 /7
|
2.73 mg/dL
Interval 2.1 to 3.6
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 47 /14
|
2.61 mg/dL
Interval 1.9 to 3.4
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 48 /25
|
2.43 mg/dL
Interval 1.9 to 3.0
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 49 /38
|
2.07 mg/dL
Interval 1.6 to 2.6
|
—
|
—
|
|
Evaluation of Effect of Repeated SC Injections of KRN23
Ext Visit 50 /81
|
1.78 mg/dL
Interval 1.6 to 1.9
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13.5 months,(50 visits)Evaluation of effect of repeated SC injections of KRN23, compared to Placebo on bone mineral density, bone quality and histomorphometric parameters.
Outcome measures
| Measure |
KRN23
n=1 Participants
Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
|
Bone Substudy KRN23
n=1 Participants
|
Bone Substudy Placebo
|
|---|---|---|---|
|
Evaluation of Effect of Repeated SC Injections of KRN23 in Bone Substudy
|
NA units on a scale
insufficient number of participants
|
NA units on a scale
insufficient number of participants
|
—
|
Adverse Events
KRN23
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Bone Substudy KRN23
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Bone Substudy Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KRN23
n=21 participants at risk
Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
|
Bone Substudy KRN23
n=1 participants at risk
|
Bone Substudy Placebo
n=1 participants at risk
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Vascular disorders
Hypertensive crisis
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
Other adverse events
| Measure |
KRN23
n=21 participants at risk
Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
|
Bone Substudy KRN23
n=1 participants at risk
|
Bone Substudy Placebo
n=1 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
POOR DENTAL CONDITION
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
LIP BLISTER
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/21 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
14.3%
3/21 • Number of events 3 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
LIP ULCERATION
|
0.00%
0/21 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 4 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
NAUSEA
|
9.5%
2/21 • Number of events 4 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/21 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
GINGIVAL ULCERATION
|
0.00%
0/21 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Cardiac disorders
BRADYCARDIA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Cardiac disorders
PALPITATIONS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Ear and labyrinth disorders
EAR PAIN
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Ear and labyrinth disorders
VERTIGO
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Ear and labyrinth disorders
DEAFNESS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Eye disorders
DRY EYE
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Eye disorders
EYE PRURITUS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
VOMITING
|
4.8%
1/21 • Number of events 3 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
FOOD POISONING
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
19.0%
4/21 • Number of events 6 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
14.3%
3/21 • Number of events 5 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
4.8%
1/21 • Number of events 10 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
INJECTION SITE HAEMATOMA
|
0.00%
0/21 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
INJECTION SITE ERYTHEMA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
FATIGUE
|
14.3%
3/21 • Number of events 3 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
INJECTION SITE PAIN
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 6 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
GRAVITATIONAL OEDEMA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
28.6%
6/21 • Number of events 10 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
HYPOTHERMIA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
APPLICATION SITE REACTION
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
PAIN
|
4.8%
1/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
NODULE
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
INJECTION SITE REACTION
|
23.8%
5/21 • Number of events 26 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
INJECTION SITE RASH
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
General disorders
INJECTION SITE PRURITUS
|
4.8%
1/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Immune system disorders
SEASONAL ALLERGY
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
VIRAL PHARYNGITIS
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
VIRAL INFECTION
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
TOOTH INFECTION
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
SINUSITIS
|
28.6%
6/21 • Number of events 7 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
9.5%
2/21 • Number of events 3 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
TOOTH ABSCESS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
VAGINITIS BACTERIAL
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
PHARYNGITIS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.5%
2/21 • Number of events 3 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
LARYNGITIS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
INFLUENZA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
EAR INFECTION
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
14.3%
3/21 • Number of events 3 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
BRONCHITIS
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Infections and infestations
GASTROENTERITIS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Injury, poisoning and procedural complications
GINGIVAL INJURY
|
0.00%
0/21 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Injury, poisoning and procedural complications
CONTUSION
|
4.8%
1/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
14.3%
3/21 • Number of events 3 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL SWELLING
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Investigations
BLOOD PRESSURE DECREASED
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
4.8%
1/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
4.8%
1/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
19.0%
4/21 • Number of events 4 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
9.5%
2/21 • Number of events 6 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
JOINT CREPITATION
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
HAEMARTHROSIS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINAL STENOSIS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
23.8%
5/21 • Number of events 6 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
SYNCOPE
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
SINUS HEADACHE
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
SCIATICA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
14.3%
3/21 • Number of events 3 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
PARAESTHESIA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
NEURITIS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
MIGRAINE
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
HYPOAESTHESIA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
HEADACHE
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 6 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
DYSKINESIA
|
4.8%
1/21 • Number of events 5 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
DIZZINESS
|
19.0%
4/21 • Number of events 4 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Nervous system disorders
BURNING SENSATION
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Psychiatric disorders
INSOMNIA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Psychiatric disorders
DEPRESSION
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Renal and urinary disorders
RENAL PAIN
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Renal and urinary disorders
POLLAKIURIA
|
9.5%
2/21 • Number of events 5 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Renal and urinary disorders
HYPERCALCIURIA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Renal and urinary disorders
HAEMATURIA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Renal and urinary disorders
DYSURIA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Respiratory, thoracic and mediastinal disorders
TONSILLAR HYPERTROPHY
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/21 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
100.0%
1/1 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RESPIRATORY SYMPTOM
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Skin and subcutaneous tissue disorders
SKIN REACTION
|
4.8%
1/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Skin and subcutaneous tissue disorders
RASH
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
9.5%
2/21 • Number of events 2 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Vascular disorders
VARICOSE VEIN
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
|
Vascular disorders
HOT FLUSH
|
4.8%
1/21 • Number of events 1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
0.00%
0/1 • After the first dose of study drug in study through the end of study, up to 13.5 months
|
Additional Information
Kyowa Kirin Pharmaceutical Development
Kyowa Kirin Pharmaceutical Development
Phone: 609-919-1100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60