Trial Outcomes & Findings for A Study of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee (NCT NCT02495857)
NCT ID: NCT02495857
Last Updated: 2020-06-23
Results Overview
The primary effectiveness endpoint was the change from Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC®) pain score in the target knee at Week 26.The validated WOMAC was used to assess pain, stiffness, and physical function of the target knee.The range of pain score was 0 to 500 mm with higher scores for worse pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
599 participants
Primary outcome timeframe
Baseline and 26 weeks
Results posted on
2020-06-23
Participant Flow
The populations for this study included the Safety Population, the modified Intent-to-Treat (mITT) population, and the Per-Protocol (PP) Population.
Participant milestones
| Measure |
Hyaluronate Injectable Viscosupplement
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Euflexxa IA Injection
Patients received intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Placebo Solution
Patients received intra-articular (IA) injection of 2mL to the knee once weekly for 3 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
200
|
200
|
199
|
|
Overall Study
COMPLETED
|
178
|
184
|
181
|
|
Overall Study
NOT COMPLETED
|
22
|
16
|
18
|
Reasons for withdrawal
| Measure |
Hyaluronate Injectable Viscosupplement
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Euflexxa IA Injection
Patients received intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Placebo Solution
Patients received intra-articular (IA) injection of 2mL to the knee once weekly for 3 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
10
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
3
|
|
Overall Study
Other
|
3
|
3
|
2
|
Baseline Characteristics
A Study of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
Generic Hyaluronate Injectable, 1%
n=200 Participants
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Euflexxa Injection 1%
n=200 Participants
Patients received intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Vehicle Solution
n=199 Participants
Patients received intra-articular (IA) injection of 2mL to the knee once weekly for 3 weeks.
|
Total
n=599 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 9.36 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 9.62 • n=4 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
348 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
70 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
130 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
421 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
163 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
484 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 26 weeksPopulation: Intention-To-Treat (ITT) Population
The primary effectiveness endpoint was the change from Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC®) pain score in the target knee at Week 26.The validated WOMAC was used to assess pain, stiffness, and physical function of the target knee.The range of pain score was 0 to 500 mm with higher scores for worse pain.
Outcome measures
| Measure |
Generic Hyaluronate Injectable, 1%
n=200 Participants
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Euflexxa Injection 1%
n=200 Participants
Patients received intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Vehicle Solution
n=199 Participants
Patients received intra-articular (IA) injection of 2mL to the knee once weekly for 3 weeks.
|
|---|---|---|---|
|
Change From Baseline in the WOMAC Pain Score in the Target Knee at Week 26 [Western Ontario and McMaster Universities Arthritis Index (WOMAC®)]
|
-51.43 Percentage of change from baseline
Standard Deviation 41.012
|
-54.49 Percentage of change from baseline
Standard Deviation 37.042
|
-36.86 Percentage of change from baseline
Standard Deviation 52.826
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Intention-To-Treat (ITT) Population
The change from Baseline in the WOMAC pain score over time (baseline to Week 1, Week 6, Week 12 and Week 26) using Western Ontario and McMaster Universities Arthritis Index (WOMAC®)\].The validated WOMAC was used to assess pain, stiffness, and physical function of the target knee.The range of pain score was 0 to 500 mm with higher scores for worse pain.
Outcome measures
| Measure |
Generic Hyaluronate Injectable, 1%
n=200 Participants
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Euflexxa Injection 1%
n=200 Participants
Patients received intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Vehicle Solution
n=199 Participants
Patients received intra-articular (IA) injection of 2mL to the knee once weekly for 3 weeks.
|
|---|---|---|---|
|
Change in Pain Over Time From Baseline to Week 1, Week 6, Week 12 and Week 26
Week 1
|
-14.10 percentage of change from baseline
Standard Deviation 30.568
|
-15.13 percentage of change from baseline
Standard Deviation 27.341
|
-15.08 percentage of change from baseline
Standard Deviation 32.680
|
|
Change in Pain Over Time From Baseline to Week 1, Week 6, Week 12 and Week 26
Week 6
|
-46.28 percentage of change from baseline
Standard Deviation 41.042
|
-49.91 percentage of change from baseline
Standard Deviation 35.543
|
-33.96 percentage of change from baseline
Standard Deviation 68.782
|
|
Change in Pain Over Time From Baseline to Week 1, Week 6, Week 12 and Week 26
Week 12
|
-51.96 percentage of change from baseline
Standard Deviation 40.894
|
-52.47 percentage of change from baseline
Standard Deviation 35.749
|
-39.16 percentage of change from baseline
Standard Deviation 58.080
|
|
Change in Pain Over Time From Baseline to Week 1, Week 6, Week 12 and Week 26
Week 26
|
-51.43 percentage of change from baseline
Standard Deviation 41.012
|
-54.49 percentage of change from baseline
Standard Deviation 37.042
|
-36.86 percentage of change from baseline
Standard Deviation 52.826
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Intention-To-Treat (ITT) Population
The change from baseline in the stiffness in the target knee at Week 26. The validated WOMAC was used to assess pain, stiffness, and physical function of the target knee.The range of stiffness score was 0 to 100 mm with higher scores for worse stiffness.
Outcome measures
| Measure |
Generic Hyaluronate Injectable, 1%
n=200 Participants
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Euflexxa Injection 1%
n=200 Participants
Patients received intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Vehicle Solution
n=199 Participants
Patients received intra-articular (IA) injection of 2mL to the knee once weekly for 3 weeks.
|
|---|---|---|---|
|
Change in Stiffness of the Knee After 26 Weeks as Measured by the WOMAC Pain Score in the Target Knee at Week 26 [Western Ontario and McMaster Universities Arthritis Index (WOMAC®)]
|
-47.37 percentage of change from baseline
Standard Deviation 45.275
|
-47.25 percentage of change from baseline
Standard Deviation 63.020
|
-35.77 percentage of change from baseline
Standard Deviation 63.103
|
Adverse Events
Generic Hyaluronate Injectable, 1%
Serious events: 5 serious events
Other events: 76 other events
Deaths: 0 deaths
Euflexxa Injection 1%
Serious events: 2 serious events
Other events: 82 other events
Deaths: 0 deaths
Vehicle Solution
Serious events: 3 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Generic Hyaluronate Injectable, 1%
n=199 participants at risk
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Euflexxa Injection 1%
n=199 participants at risk
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Vehicle Solution
n=197 participants at risk
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Cardiac disorders
Cardiomyopathy
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
Other adverse events
| Measure |
Generic Hyaluronate Injectable, 1%
n=199 participants at risk
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Euflexxa Injection 1%
n=199 participants at risk
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
Vehicle Solution
n=197 participants at risk
Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Cardiac disorders
Cardiomyopathy
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Eye disorders
Cataract
|
0.50%
1/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Eye disorders
Conjunctivitis allergic
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Eye disorders
Eyelid cyst
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
2/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
General disorders
Injection site joint pain
|
2.5%
5/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
6.1%
12/197 • Data was collected for 26 weeks.
|
|
General disorders
Injection site joint effusion
|
0.50%
1/199 • Data was collected for 26 weeks.
|
2.0%
4/199 • Data was collected for 26 weeks.
|
1.5%
3/197 • Data was collected for 26 weeks.
|
|
General disorders
Injection site joint swelling
|
0.50%
1/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
1.5%
3/197 • Data was collected for 26 weeks.
|
|
General disorders
Injection site pain
|
1.0%
2/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
General disorders
Oedema peripheral
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
1.0%
2/197 • Data was collected for 26 weeks.
|
|
General disorders
Injection site erythema
|
0.00%
0/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
General disorders
Injection site warmth
|
0.00%
0/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
General disorders
Pain
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
General disorders
Asthenia
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
General disorders
Fatigue
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
General disorders
Injection site bruising
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
General disorders
Injection site reaction
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
General disorders
Injection site swelling
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
General disorders
Mass
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
General disorders
Pyrexia
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
General disorders
Swelling
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
General disorders
Tenderness
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
7/199 • Data was collected for 26 weeks.
|
3.5%
7/199 • Data was collected for 26 weeks.
|
1.5%
3/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
5/199 • Data was collected for 26 weeks.
|
1.5%
3/199 • Data was collected for 26 weeks.
|
4.1%
8/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Bronchitis
|
2.5%
5/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
2/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
1.0%
2/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
1.5%
3/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Diverticulitis
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Ear infection
|
0.00%
0/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Herpes zoster
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Pharyngitis
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Cystitis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Eye infection
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Injection site infection
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Oophoritis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Otitis media
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Parotitis
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Rhinitis
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Viral infection
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Intervertebral disc injury
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Investigations
Blood pressure increased
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Investigations
Blood glucose increased
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Investigations
Cardiac murmur
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Investigations
Heart rate irregular
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
19/199 • Data was collected for 26 weeks.
|
13.1%
26/199 • Data was collected for 26 weeks.
|
12.2%
24/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.5%
5/199 • Data was collected for 26 weeks.
|
1.5%
3/199 • Data was collected for 26 weeks.
|
3.6%
7/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
2.5%
5/199 • Data was collected for 26 weeks.
|
1.5%
3/199 • Data was collected for 26 weeks.
|
2.0%
4/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.0%
4/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
2.0%
4/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
2/199 • Data was collected for 26 weeks.
|
1.5%
3/199 • Data was collected for 26 weeks.
|
1.5%
3/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
1.0%
2/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
3/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/199 • Data was collected for 26 weeks.
|
1.5%
3/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.50%
1/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Plantar fascitis
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint warmth
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Nervous system disorders
Headache
|
1.5%
3/199 • Data was collected for 26 weeks.
|
1.5%
3/199 • Data was collected for 26 weeks.
|
2.5%
5/197 • Data was collected for 26 weeks.
|
|
Nervous system disorders
Presyncope
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
1.0%
2/197 • Data was collected for 26 weeks.
|
|
Nervous system disorders
Sciatica
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Nervous system disorders
Sinus headache
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Nervous system disorders
Balance disorder
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Nervous system disorders
Dizziness
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Psychiatric disorders
Depression
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
1.0%
2/197 • Data was collected for 26 weeks.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Renal and urinary disorders
Renal pain
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
3/199 • Data was collected for 26 weeks.
|
1.0%
2/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
1.0%
2/197 • Data was collected for 26 weeks.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.51%
1/197 • Data was collected for 26 weeks.
|
|
Vascular disorders
Hypertension
|
0.50%
1/199 • Data was collected for 26 weeks.
|
0.00%
0/199 • Data was collected for 26 weeks.
|
0.00%
0/197 • Data was collected for 26 weeks.
|
Additional Information
Senior Director, Clinical R&D
Teva Pharmaceuticals Inc. USA
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER